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    Chemistry

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    Also known as: 171228-49-2, Noxafil, Sch 56592, Sch-56592, Posaconazole sp, Sch56592
    Molecular Formula
    C37H42F2N8O4
    Molecular Weight
    700.8  g/mol
    InChI Key
    RAGOYPUPXAKGKH-XAKZXMRKSA-N
    FDA UNII
    6TK1G07BHZ
    Posaconazole
    Posaconazole is a broad-spectrum, second generation, triazole compound with antifungal activity. Posaconazole strongly inhibits 14-alpha demethylase, a cytochrome P450-dependent enzyme. Inhibition of 14-alpha-demethylase prevents the conversion of lanosterol to ergosterol, an important component of the fungal cell wall. Inhibition of ergosterol synthesis changes the fungal cell membrane composition and integrity, alters membrane permeability and eventually leads to fungal cell lysis. Compared to other azole antifungals, posaconazole is a significantly more potent inhibitor of sterol 14-alpha demethylase.
    Posaconazole is an Azole Antifungal.
    1 2D Structure

    Posaconazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
    2.1.2 InChI
    InChI=1S/C37H42F2N8O4/c1-3-35(26(2)48)47-36(49)46(25-42-47)31-7-5-29(6-8-31)43-14-16-44(17-15-43)30-9-11-32(12-10-30)50-20-27-19-37(51-21-27,22-45-24-40-23-41-45)33-13-4-28(38)18-34(33)39/h4-13,18,23-27,35,48H,3,14-17,19-22H2,1-2H3/t26-,27+,35-,37-/m0/s1
    2.1.3 InChI Key
    RAGOYPUPXAKGKH-XAKZXMRKSA-N
    2.1.4 Canonical SMILES
    CCC(C(C)O)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OCC5CC(OC5)(CN6C=NC=N6)C7=C(C=C(C=C7)F)F
    2.1.5 Isomeric SMILES
    CC[C@@H]([C@H](C)O)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OC[C@H]5C[C@](OC5)(CN6C=NC=N6)C7=C(C=C(C=C7)F)F
    2.2 Other Identifiers
    2.2.1 UNII
    6TK1G07BHZ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-(p-(4-(p-(((3r,5r)-5-(2,4-difluorophenyl)tetrahydro-5-(1h-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1s,2s)-1-ethyl-2-hydroxypropyl)-delta(sup 2)-1,2,4-triazolin-5-one

    2. Noxafil

    3. Posaconazole Hydrate

    4. Sch 56592

    5. Sch-56592

    2.3.2 Depositor-Supplied Synonyms

    1. 171228-49-2

    2. Noxafil

    3. Sch 56592

    4. Sch-56592

    5. Posaconazole Sp

    6. Sch56592

    7. Schering 56592

    8. 4-(4-(4-(4-(((3r,5r)-5-((1h-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2s,3s)-2-hydroxypentan-3-yl)-1h-1,2,4-triazol-5(4h)-one

    9. 4-[4-[4-[4-[[(3r,5r)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2s,3s)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one

    10. 6tk1g07bhz

    11. Chembl1397

    12. Chebi:64355

    13. 177571-33-4

    14. 2,5-anhydro-1,3,4-trideoxy-2-(2,4-difluorophenyl)-4-({4-[4-(4-{1-[(2s,3s)-2-hydroxypentan-3-yl]-5-oxo-1,5-dihydro-4h-1,2,4-triazol-4-yl}phenyl)piperazin-1-yl]phenoxy}methyl)-1-(1h-1,2,4-triazol-1-yl)-d-threo-pentitol

    15. D-threo-pentitol, 2,5-anhydro-1,3,4-trideoxy-2-c-(2,4-difluorophenyl)- 4-((4-(4-(4-(1-((1s,2s)-1-ety

    16. Pos

    17. Unii-6tk1g07bhz

    18. Pasaconazole

    19. Posaconazole [usan:inn:ban]

    20. Hsdb 7421

    21. 4-[4-[4-[4-[[(3r,5r)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1s,2s)-1-ethyl-2-hydroxy-propyl]-1,2,4-triazol-3-one

    22. Noxafil (tn)

    23. Posaconazole Solution

    24. Posaconazole- Bio-x

    25. Posaconazole - Form I

    26. Posaconazole - Form Iii

    27. Posaconazole [mi]

    28. (-)-posaconazole

    29. Posaconazole [inn]

    30. Posaconazole [jan]

    31. Posaconazole [hsdb]

    32. Posaconazole [usan]

    33. Posaconazole [vandf]

    34. Posaconazole [mart.]

    35. Posaconazole [who-dd]

    36. Schembl991747

    37. Posaconazole (jan/usan/inn)

    38. Posaconazole [ema Epar]

    39. Dtxsid6049066

    40. Gtpl11428

    41. Posaconazole [green Book]

    42. Posaconazole [orange Book]

    43. Amy30591

    44. Bcp01102

    45. Zinc3938482

    46. Bdbm50181473

    47. Mfcd00941162

    48. Mmv688774

    49. S1257

    50. Akos005145917

    51. Ac-1350

    52. Ccg-270387

    53. Cs-0998

    54. Db01263

    55. Ks-1413

    56. Ncgc00274060-02

    57. Ncgc00274060-07

    58. 4-(p-(4-(p-(((3r,5r)-5-(2,4-difluorophenyl)tetrahydro-5-(1h-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1s,2s)-1-ethyl-2-hydroxypropyl)-delta(sup 2)-1,2,4-triazolin-5-one

    59. Bp163592

    60. Bp163593

    61. Bp164281

    62. Hy-17373

    63. Posaconazole In Combination With Mgcd290

    64. P2477

    65. Sw219391-1

    66. D02555

    67. P-7020

    68. Ab01274762-01

    69. Ab01274762_02

    70. Posaconazole, Vetranal(tm), Analytical Standard

    71. 228p492

    72. Q906453

    73. Posaconazole, Antibiotic For Culture Media Use Only

    74. Posaconazole Solution, 2.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    75. 1-((1s,2s)-1-ethyl-2-hydroxypropyl)-4-{4-[4-(4-{[(5s,3r)-5-(2,4-difluorophenyl)-5-(1,2,4-triazolylmethyl)oxolan-3-yl]methoxy}phenyl)piperazinyl]phenyl}-1,2,4-triazolin-5-one

    76. 2,5-anhydro-1,3,4-trideoxy-2-(2,4-difluorophenyl)-4-({4-[4-(4-{1-[(1s,2s)-1-ethyl-2-hydroxypropyl]-5-oxo-1,5-dihydro-4h-1,2,4-triazol-4-yl}phenyl)piperazin-1-yl]phenoxy}methyl)-1-(1h-1,2,4-triazol-1-yl)-d-threo-pentitol

    77. 3h-1,2,4-triazol-3-one, 4-(4-(4-(4-((5-(2,4-difluorophenyl)tetrahydro-5-(1h-1,2,4-triazol-1-ylmethyl)-3-furanyl)methoxy)phenyl)-1-piperazinyl)phenyl)-2-(1-ethyl-2-hydroxypropyl)-2,4-dihydro-, (3r-(3.alpha.(1s*,2s*),5.alpha.))-

    78. 3h-1,2,4-triazol-3-one, 4-(4-(4-(4-((5-(2,4-difluorophenyl)tetrahydro-5-(1h-1,2,4-triazol-1-ylmethyl)-3-furanyl)methoxy)phenyl)-1-piperazinyl)phenyl)-2-(1-ethyl-2-hydroxypropyl)-2,4-dihydro-, (3r-(3alpha(1s*,2s*),5alpha))-

    79. 4-(4-(4-(4-(((3r,5r)-5-((1h-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2s,3s)-2-hydroxypentan-3-yl)-2h-1,2,4-triazol-3(4h)-one

    80. 4-(4-(4-(4-(((3r,5r)-5-((1h-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2s,3s)-2-hydroxypentan-3-yl)-2,4-dihydro-3h-1,2,4-triazol-3-one

    81. 4-(4-(4-(4-(((3r,5r)-5-(3,4-difluorophenyl)-5-(1h-1,2,4-triazol-1-yl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2s,3s)-2-hydroxypentan-3-yl)-1h-1,2,4-triazol-5(4h)-one

    82. 4-(4-(4-(4-(((5r)-5-((1h-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2s,3s)-2-hydroxypentan-3-yl)-2h-1,2,4-triazol-3(4h)-one

    83. 4-(p-(4-(p-(((3r,5r)-5-(2,4-difluorophenyl)tetrahydro-5-(1h-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1s,2s)-1-ethyl-2-hydroxypropyl)-.delta.(sup 2)-1,2,4-triazolin-5-one

    84. 4-[4-(4-{4-[(r)-5-(2,4-difluoro-phenyl)-5-(4,5-dihydro-[1,2,4]triazol-1-ylmethyl)-tetrahydro-furan-3-ylmethoxy]-phenyl}-piperazin-1-yl)-phenyl]-2-((1s,2s)-1-ethyl-2-hydroxy-propyl)-2,4-dihydro-[1,2,4]triazol-3-one

    85. D-threo-pentitol, 2,5-anhydro-1,3,4-trideoxy-2-c-(2,4-difluorophenyl)-4-((4-(4-(4-(1-((1s,2s)-1-etyl-2-hydroxypropyl)-1,5-dihydro-5-oxo-4h-1,2,4-triazol-4-yl)phenyl)-1-piperazinyl)phenoxy)methyl)-1-(1h-1,2,4-triazol-1-yl)-

    86. D-threo-pentitol, 2,5-anhydro-1,3,4-trideoxy-2-c-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-[(1s,2s)-1-ethyl-2-hydroxypropyl]-1,5-dihydro-5-oxo-4h-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]methyl]-1-( 1h-1,2,4-triazol-1-yl)-?

    87. Pcz

    2.4 Create Date
    2005-08-01
    3 Chemical and Physical Properties
    Molecular Weight 700.8 g/mol
    Molecular Formula C37H42F2N8O4
    XLogP34.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count12
    Exact Mass700.32970817 g/mol
    Monoisotopic Mass700.32970817 g/mol
    Topological Polar Surface Area112 Ų
    Heavy Atom Count51
    Formal Charge0
    Complexity1170
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNoxafil
    PubMed HealthPosaconazole
    Drug ClassesAntifungal
    Drug LabelNoxafil is an azole antifungal agent available as concentrated solution to be diluted before intravenous administration, delayed-release tablet, or suspension for oral administration.Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (...
    Active IngredientPosaconazole
    Dosage FormSuspension; Tablet, delayed release; Solution
    Routeoral; Iv (infusion); Oral
    Strength300mg/16.7ml (18mg/ml); 100mg; 40mg/ml
    Market StatusPrescription
    CompanyMerck Sharp Dohme; Schering

    2 of 2  
    Drug NameNoxafil
    PubMed HealthPosaconazole
    Drug ClassesAntifungal
    Drug LabelNoxafil is an azole antifungal agent available as concentrated solution to be diluted before intravenous administration, delayed-release tablet, or suspension for oral administration.Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (...
    Active IngredientPosaconazole
    Dosage FormSuspension; Tablet, delayed release; Solution
    Routeoral; Iv (infusion); Oral
    Strength300mg/16.7ml (18mg/ml); 100mg; 40mg/ml
    Market StatusPrescription
    CompanyMerck Sharp Dohme; Schering

    4.2 Therapeutic Uses

    Mesh Heading: Antibiotics, antifungals, trypanocidal agents

    National Library of Medicine, SIS; ChemIDplus Record for Posaconazole (171228-49-2). Available from, as of April 14, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

    MEDICATION: Antifungal; Orally activated triazole antifungal

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1365

    The pharmacokinetics of posaconazole oral suspension in neutropenic patients undergoing high-dose chemotherapy and stem cell transplantation were evaluated, and the association of plasma posaconazole exposure with the presence and severity of oral mucositis was explored in this nonrandomized, open-label, parallel-group, multiple-dose pharmacokinetic study. Thirty patients were enrolled and received one of three regimens (group I, 200 mg once daily; group II, 400 mg once daily; group III, 200 mg four times daily) for the duration of neutropenia. The mean total exposure for day 1, as shown by the area under the concentration-time curve from 0 to 24 h (AUC(0-24)), was 1.96 mg . h/liter in group I and was 51% higher in group II and in group III. Increases in AUC(0-24) and maximum plasma concentration (C(max)) in groups II and III were dose related. The AUC(0-24) and C(max) values on day 1 were similar between groups II and III. There was interpatient variability of up to 68% in the pharmacokinetic values for our study population. Steady state was attained by days 5 to 6. Average steady-state plasma posaconazole trough values were 192, 219, and 414 ng/ml in groups I, II, and III, respectively. The AUC(0-24) and apparent oral clearance increased by increasing dose and dosing frequency. Mucositis appeared to reduce exposure but did not significantly affect mean total posaconazole exposure (AUC and C(max)) at steady state (P = 0.1483). Moreover, this reduction could be overcome by increasing the total dose and dosing frequency. Posaconazole was safe and well tolerated.

    PMID:16723557 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1479147 Gubbins PO et al; Antimicrob Agents Chemother 50 (6): 1993-9 (2006)

    /EXPTL:/ ... Posaconazole has demonstrated strong antifungal efficacy in Phase II and III clinical trials in immunocompromised patients with oropharyngeal and esophageal candidiasis. Posaconazole also showed promising efficacy as salvage therapy in a large Phase II study including 330 patients with invasive fungal infections intolerant to or refractory to standard therapies. ...

    PMID:16107193 Groll AH et al; Expert Rev Anti Infect Ther 3 (4): 467-87 (2005)

    4.3 Drug Warning

    Invasive fungal infections are found most frequently in immunosuppressed and critically ill hospitalized patients. Antifungal therapy is often required for long periods. Safety data from the clinical development program of the triazole antifungal agent, posaconazole, were analyzed. A total of 428 patients with refractory invasive fungal infections (n = 362) or febrile neutropenia (n = 66) received posaconazole in 2 phase II/III open-label clinical trials. Also, 109 of these patients received posaconazole therapy for > or = 6 months. Incidences of treatment-emergent, treatment-related, and serious adverse events and abnormal laboratory parameters were recorded during these studies. Treatment-emergent, treatment-related adverse events were reported in 38% of the overall patient population. The most common treatment-related adverse events were nausea (8%) and vomiting (6%). Treatment-related serious adverse events occurred in 8% of patients. Low rates of treatment-related corrected QT interval and/or QT interval prolongation (1%) and elevation of hepatic enzymes (2%) were reported as adverse events. Treatment-emergent, treatment-related adverse events occurred at similar rates in patients who received posaconazole therapy for < 6 months and > or = 6 months. Prolonged posaconazole treatment was associated with a generally favorable safety profile in seriously ill patients with refractory invasive fungal infections. Long-term therapy did not increase the risk of any individual adverse event, and no unique adverse event was observed with longer exposure to posaconazole.

    PMID:16705579 Raad II et al; Clin Infect Dis 42 (12): 1726-34 (2006)

    The pharmacokinetic profiles, safety, and efficacies of different dosing schedules of posaconazole oral suspension in patients with possible, probable, and proven refractory invasive fungal infection (rIFI) or febrile neutropenia (FN) were evaluated in a multicenter, open-label, parallel-group study. Sixty-six patients with FN and 32 patients with rIFI were randomly assigned to one of three posaconazole regimens: 200 mg four times a day (q.i.d.) for nine doses, followed by 400 mg twice a day (b.i.d.); 400 mg q.i.d. for nine doses, followed by 600 mg b.i.d.; or 800 mg b.i.d. for five doses, followed by 800 mg once a day (q.d.). Therapy was continued for up to 6 months in patients with rIFI or until neutrophil recovery occurred in patients with FN. The 400-mg-b.i.d. dose provided the highest overall mean exposure, with 135% (P = 0.0004) and 182% (P < 0.0001) greater exposure than the 600-mg-b.i.d. and 800-mg-q.d. doses, respectively. However, exposure in allogeneic bone marrow transplant (BMT) recipients (n = 12) was 52% lower than in non-BMT patients. Treatment-related adverse events (occurring in 24% of patients) were mostly gastrointestinal in nature. Twenty-four percent of patients had adverse events leading to premature discontinuation (none were treatment related). In efficacy-evaluable patients, successful clinical response was observed in 43% with rIFI (56% of patients receiving 400 mg b.i.d., 17% receiving 600 mg b.i.d., and 50% receiving 800 mg q.d.) and 77% with FN (74% receiving 400 mg b.i.d., 78% receiving 600 mg b.i.d., and 81% receiving 800 mg q.d.). Posaconazole is well tolerated and absorbed. Divided doses of 800 mg (400 mg b.i.d.) provide the greatest posaconazole exposure.

    PMID:16436724 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1366875 Ullmann AJ et al; Antimicrob Agents Chemother 50 (2): 658-66 (2006)

    The authors evaluated the pharmacokinetics and safety of posaconazole in healthy subjects and in those with mild (CL(CR) = 50-80 mL/min), moderate (CL(CR) = 20-49 mL/min), and severe chronic renal disease (CL(CR) <20 mL/min; receiving outpatient hemodialysis) (n = 6/group). Subjects received one 400-mg dose of posaconazole oral suspension with a standardized high-fat breakfast. For hemodialysis-dependent subjects, this dose was given on a nonhemodialysis day, and a second 400-mg dose was given 6 hours before hemodialysis. ...There was no correlation between posaconazole pharmacokinetics and mild to moderate renal disease ...Furthermore, the difference in the predialyzed and postdialyzed posaconazole concentrations was only approximately 3%, supporting that posaconazole was not removed by hemodialysis. ...

    PMID:15647411 Courtney R et al; J Clin Pharmacol 45 (2): 185-92 (2005)

    4.4 Drug Indication

    For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised as a result of procedures such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or due to hematologic malignancies with prolonged neutropenia from chemotherapy. Also for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Posaconazole is used as an alternative treatment for invasive aspergillosis, Fusarium infections, and zygomycosis in patients who are intolerant of, or whose disease is refractory to, other antifungals.

    FDA Label

    Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 and 5. 1):

    - Invasive aspergillosis

    Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 and 5. 1):

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 and 5. 1):

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

    Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 and 5. 1):

    - Invasive aspergillosis

    Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 and 5. 1):

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 and 5. 1):

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.

    Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

    Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 and 5. 1):

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age:

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

    Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

    Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;

    - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

    Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:

    - Invasive aspergillosis;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients:

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults:

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

    - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):

    - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;

    - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;

    - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;

    - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;

    - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.

    Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

    Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:

    - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are

    at high risk of developing invasive fungal infections;

    - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

    Prevention of invasive fungal infections, Treatment of invasive fungal infections

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Posaconazole is an antifungal agent structurally related to itraconazole. It is a drug derived from itraconzaole through the replacement of the chlorine substituents with flourine in the phenyl ring, as well as hydroxylation of the triazolone side chain. These modifications enhance the potency and spectrum of activity of the drug. Posaconazole can be either fungicial or fungistatic in action.

    5.2 MeSH Pharmacological Classification

    Trypanocidal Agents

    Agents destructive to the protozoal organisms belonging to the suborder TRYPANOSOMATINA. (See all compounds classified as Trypanocidal Agents.)

    14-alpha Demethylase Inhibitors

    Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)

    Antifungal Agents

    Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    POSACONAZOLE
    5.3.2 FDA UNII
    6TK1G07BHZ
    5.3.3 Pharmacological Classes
    Azoles [CS]; Azole Antifungal [EPC]
    5.4 ATC Code

    J02AC04

    J02AC04

    J02AC04

    J02AC04

    J - Antiinfectives for systemic use

    J02 - Antimycotics for systemic use

    J02A - Antimycotics for systemic use

    J02AC - Triazole and tetrazole derivatives

    J02AC04 - Posaconazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    Posaconazole is absorbed with a median Tmax of approximately 3 to 5 hours.

    Route of Elimination

    The excreted metabolites in urine and feces account for ~17% of the administered radiolabeled dose.

    Volume of Distribution

    1774 L

    Clearance

    32 L/hr

    51 L/hr [Single-Dose Suspension Administration of 200 mg, fasted]

    21 L/hr [Single-Dose Suspension Administration of 200 mg, nonfat meal]

    14 L/hr [Single-Dose Suspension Administration of 200 mg, high fat meal]

    91 L/hr [Single-Dose Suspension Administration of 400 mg, fasted]

    43 L/hr [Single-Dose Suspension Administration of 400 mg with liquid nutritional supplement (14 g fat)]

    Kinetics and protein binding following oral posaconazole dosing were performed in neutropenic infected mice. Peak levels and AUC from 0 hr to infinity values were nonlinear over the 16-fold dose range studied. Serum drug elimination half-life ranged from 12.0 to 17.7 hr

    PMID:14693531 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC310197 Andes D et al; Antimicrob Agents Chemother 48 (1): 137-42 (2004)

    The suspension formulation of posaconazole was associated with enhanced systemic exposure and increased relative bioavailability compared with the tablet. Food substantially enhanced the rate and extent of posaconazole absorption in healthy subjects.

    Courtney R et al; Br J Clin Pharmacol. 2004 Feb;57(2):218-22

    A total of 103 healthy adults were enrolled in two phase I trials. Each study had a double-blind, placebo-controlled, parallel-group design with a rising single-dose (RSD) or rising multiple-dose (RMD) scheme. In the RSD study, subjects received single doses of posaconazole oral tablets (50 to 1200 mg) or placebo. In the RMD study, subjects received posaconazole oral tablets (50 to 400 mg) or placebo twice daily for 14 days. By using model-independent methods, the area under the plasma concentration-time curve and the maximum concentration in plasma were determined and used to assess dose proportionality. In the RSD study, the levels of posaconazole in plasma increased proportionally between the 50- and 800-mg dose range, with saturation of absorption occurring above 800 mg. Dose proportionality was also observed in the RMD study. In both studies, the apparent volume of distribution was large (range, 343 to 1341 liters) and the terminal-phase half-life was long (range, 25 to 31 hr).

    PMID:12936975 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC182636 Courtney R et al; Antimicrob Agents Chemother 47 (9): 2788-95 (2003)

    Subjects fasted 12 hours before and 48 hours after the administration of posaconazole oral suspension (800 mg) given as a single dose (regimen A), 400 mg every 12 hours (regimen B) or 200 mg every 6 hours (regimen C). Plasma posaconazole concentrations were determined for 48 hours after the initial dose and subjects completed a 1-week washout period between treatment regimens. A one-compartment oral model with first-order rate of absorption and first-order rate of elimination was fitted to the plasma concentration-time data. Differences in exposure were investigated by allowing the bioavailability fraction to vary among regimens. A total of 18 healthy men were enrolled in and completed the study. : Posaconazole relative bioavailability was estimated to be significantly different among regimens (p < 0.0001) and increased with the number of doses, such that regimen B/regimen A = 1.98 +/- 0.35, representing a 98% increase, and regimen C/regimen A = 3.20 +/- 0.69, or a 220% increase. With use of the one-compartment model, the population steady-state values for area under the concentration-time curve over 24 hours were predicted to be 3900, 7700 and 12 400 microg.h/L, with average plasma concentrations of 162, 320 and 517 microg/L for regimens A, B and C, respectively. These data suggest that divided daily dose administration (every 12 or 6 hours) significantly increases posaconazole exposure under fasted conditions.

    PMID:15656699 Ezzet F et al; Clin Pharmacokinet 44 (2): 211-20 (2005)

    For more Absorption, Distribution and Excretion (Complete) data for POSACONAZOLE (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Posaconazole primarily circulates as the parent compound in plasma. Of the circulating metabolites, the majority are glucuronide conjugates formed via UDP glucuronidation (phase 2 enzymes). Posaconazole does not have any major circulating oxidative (CYP450 mediated) metabolites. The excreted metabolites in urine and feces account for ~17% of the administered radiolabeled dose.

    5.7 Biological Half-Life

    Posaconazole is eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).

    The i.v. terminal-phase half-lives were 7 hr in mice and rats, 15 hr in dogs, and 23 hr in monkeys. In rabbits, the oral half-life was 9 hr.

    PMID:10681346 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC89754 Nomeir AA et al; Antimicrob Agents Chemother 44 (3): 727-31 (2000)

    Kinetics and protein binding following oral posaconazole dosing were performed in neutropenic infected mice. Peak levels and AUC from 0 hr to infinity values were nonlinear over the 16-fold dose range studied. Serum drug elimination half-life ranged from 12.0 to 17.7 hr

    PMID:14693531 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC310197 Andes D et al; Antimicrob Agents Chemother 48 (1): 137-42 (2004)

    5.8 Mechanism of Action

    As a triazole antifungal agent, posaconazole exerts its antifungal activity through blockage of the cytochrome P-450 dependent enzyme, sterol 14α-demethylase, in fungi by binding to the heme cofactor located on the enzyme. This leads to the inhibition of the synthesis of ergosterol, a key component of the fungal cell membrane, and accumulation of methylated sterol precursors. This results in inhibition of fungal cell growth and ultimately, cell death.

    Posaconazole is a novel lipophilic antifungal triazole that inhibits cytochrome P450-dependent 14-alpha demethylase in the biosynthetic pathway of ergosterol. Inhibition of this enzyme leads to an accumulation of toxic 14-alpha methylsterols and a depletion of ergosterol, resulting in a perturbation of the function of the fungal cell membrane and blockage of cell growth and division. ...

    PMID:16107193 Groll AH et al; Expert Rev Anti Infect Ther 3 (4): 467-87 (2005)

    ... The primary mechanism of action of the drug was inhibition of the parasite's sterol C-14 alpha demethylase.

    PMID:9661019 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC105681 Urbina JA et al; Antimicrob Agents Chemother 42 (7): 1771-7 (1998)

    The in vitro activity of the novel triazole antifungal agent posaconazole was assessed in 45 laboratories against approximately 19,000 clinically important strains of yeasts and molds. The activity of posaconazole was compared with those of itraconazole, fluconazole, voriconazole, and amphotericin B against subsets of the isolates. Strains were tested utilizing Clinical and Laboratory Standards Institute broth microdilution methods using RPMI 1640 medium (except for amphotericin B, which was frequently tested in antibiotic medium 3). MICs were determined at the recommended endpoints and time intervals. Against all fungi in the database (22,850 MICs), the MIC(50) and MIC(90) values for posaconazole were 0.063 microg/ml and 1 mug/ml, respectively. MIC(90) values against all yeasts (18,351 MICs) and molds (4,499 MICs) were both 1 mug/ml. In comparative studies against subsets of the isolates, posaconazole was more active than, or within 1 dilution of, the comparator drugs itraconazole, fluconazole, voriconazole, and amphotericin B against approximately 7,000 isolates of Candida and Cryptococcus spp. Against all molds (1,702 MICs, including 1,423 MICs for Aspergillus isolates), posaconazole was more active than or equal to the comparator drugs in almost every category. Posaconazole was active against isolates of Candida and Aspergillus spp. that exhibit resistance to fluconazole, voriconazole, and amphotericin B and was much more active than the other triazoles against zygomycetes. Posaconazole exhibited potent antifungal activity against a wide variety of clinically important fungal pathogens and was frequently more active than other azoles and amphotericin B.

    PMID:16723559 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1479149 Sabatelli F et al; Antimicrob Agents Chemother 50 (6): 2009-15 (2006)

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    Listed Suppliers

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    01

    Transo-Pharm USA LLC

    U.S.A
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    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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    Posaconazole

    About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

    Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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    02

    LGM Pharma

    U.S.A
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Posaconazole

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    03

    Metrochem API Private Limited

    India
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Posaconazole

    About the Company :

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    04

    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Posaconazole

    About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

    Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.
    Cohance

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    05

    Dr. Reddy's Laboratories

    India
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    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Posaconazole

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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    06

    HRV Global Life Sciences

    India
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Posaconazole

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    07

    Neuland Laboratories

    India
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    DCAT Week
    Exhibiting
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    Posaconazole

    About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

    Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
    Neuland

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    08

    Shanghai Minbiotech

    China
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    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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    Posaconazole

    About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

    ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
    Shanghai Minbiotech CB

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    09

    Aspen Biopharma Labs

    India
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    Aspen Biopharma Labs

    India
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    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Posaconazole

    About the Company : Aspen Biopharma Labs is a multifaceted company that was established in 2014. Aspen Bio Pharma defines development and novelty as a challenge for competitive markets to provide impr...

    Aspen Biopharma Labs is a multifaceted company that was established in 2014. Aspen Bio Pharma defines development and novelty as a challenge for competitive markets to provide improved health services to people, through pioneering Research & Development in agreement with the latest principles to ensure safe and secured wellness. The Company is established in bringing the benefit of high quality APIs & Finished Formulations, yet reasonably priced, to patients in India and other emerging markets.
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    10

    Chromo Laboratories

    India
    Duphat
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    Chromo Laboratories

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Posaconazole

    About the Company : Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram...

    Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram, Near Patancheru, Which is 27 KM from Hyderabad. It aggressively engage in expanding product portfolio strategy and focuses on its growth . Chromo Laboratories India views its fully equipped R&D centre capabilities as a vital component of its business strategy that will provide the company with a sustainable, long-term competitive advantage. It is focusing on providing cost effective products to the Pharmaceutical Market. 
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    API Reference Price

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I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"PHILADELPHIA METROP","customer":"CATALENT PHARMA SOLUTIONS","customerCountry":"UNITED STATES","quantity":"42.00","actualQuantity":"42","unit":"KGS","unitRateFc":"9960.2","totalValueFC":"414010.3","currency":"USD","unitRateINR":717631.59523809527,"date":"02-Mar-2021","totalValueINR":"30140527","totalValueInUsd":"414010.3","indian_port":"HYDERABAD AIR","hs_no":"29093019","bill_no":"9060704","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"POSACONAZOLE","year":"2021","qtr":"Q1","strtotime":1615833000,"product":"WE INTEND TO CLAIM REWARDS UNDER REMISSI ON OF DUTIES OR TAXES ON EXPORT PRODUCTS SCHEME ( RO DTEP ) POSACONAZOLE CAS NO.","address":"303, 3RD FLOOR, ROYALE MANORLAW GARDEN, ELLISBRIDGE","city":"AHMEDABAD","supplier":"MANUS AKTTEVA BIOPHARMA ","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"LOGISTIEK PLATFORM ON","customerCountry":"BELGIUM","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"12.6","totalValueFC":"1247.6","currency":"USD","unitRateINR":908.27600000000007,"date":"16-Mar-2021","totalValueINR":"90827.6","totalValueInUsd":"1247.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"9387547","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"303, 3RD FLOOR, ROYALE MANORLAW GARDEN, ELLISBRIDGE, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"POSACONAZOLE","year":"2021","qtr":"Q2","strtotime":1619116200,"product":"POSACONAZOLE (TAX INV NO:1900206723 DT:3 1.03.2021) (GROUP:A SR NO:1146","address":"8-3-167\/D\/16, KALYAN NAGAR - 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I,VENGAL RAO NAGAR, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1623177000,"product":"POSACONAZOLE","address":"FLAT NO.204,IIND FLOOR,MERIDIANPLAZA,6-3-853\/1,AMEERPET,","city":"HYDERABAD-ANDHRA PRADESH.","supplier":"NEULAND LABORATORIES","supplierCountry":"INDIA","foreign_port":"ALMATY","customer":"JSC NOBEL ALMATINSKAYA","customerCountry":"KAZAKHSTAN","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"18005","totalValueFC":"61736.1","currency":"USD","unitRateINR":1297262.5714285714,"date":"09-Jun-2021","totalValueINR":"4540419","totalValueInUsd":"61736.1","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"2302797","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"KAZAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"FLAT NO.204,IIND FLOOR,MERIDIANPLAZA,6-3-853\/1,AMEERPET,, HYDERABAD-ANDHRA PRADESH.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1628706600,"product":"POSACONAZOLE ( TAX INV NO:1900215514 DT 31.07.2021)","address":"8-3-167\/D\/16, KALYAN NAGAR - 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    13-Jan-2021
    19-Nov-2024
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    Drugs in Development

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    Dr. Reddy's Laboratories Announces the Launch of Posaconazole Delayed-Release Tablets in the U.S. Market

    Details:

    Launch of posaconazole delayed-release tablets, 100 mg, therapeutic generic equivalent to NOXAFIL® (posaconazole) delayed-release tablets, 100 mg approved by U.S.FDA, indicated for prophylaxis of invasive aspergillus and candida infections in patients.


    Lead Product(s): Posaconazole

    Therapeutic Area: Immunology Brand Name: Posaconazole-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 20, 2022

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    Dr. Reddy's Laboratories

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    Lead Product(s) : Posaconazole

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of Posaconazole Delayed-Release Tablets in the U.S. ...

    Details : Launch of posaconazole delayed-release tablets, 100 mg, therapeutic generic equivalent to NOXAFIL® (posaconazole) delayed-release tablets, 100 mg approved by U.S.FDA, indicated for prophylaxis of invasive aspergillus and candida infections in patients.

    Brand Name : Posaconazole-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 20, 2022

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    Fresenius Launches Posaconazole Injection for Fungal Infection Prevention or Treatment

    Details:

    Noxafil-Generic (posaconazole) is a CYP451 inhibitor drug, which is indicated for invasive aspergillosis in adults and pediatric patients 13 years of age and older and candida infections.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 29, 2024

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    Fresenius Kabi USA

    U.S.A
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    Fresenius Kabi USA

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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Fresenius Launches Posaconazole Injection for Fungal Infection Prevention or Treatment

    Details : Noxafil-Generic (posaconazole) is a CYP451 inhibitor drug, which is indicated for invasive aspergillosis in adults and pediatric patients 13 years of age and older and candida infections.

    Brand Name : Noxafil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 29, 2024

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    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details:

    Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 27, 2023

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    Aurobindo Pharma Limited

    India
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    Aurobindo Pharma Limited

    India
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details : Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.

    Brand Name : Noxafil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 27, 2023

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    Endo Launches First Generic Version of Noxafil (posaconazole) Injection

    Details:

    Posaconazole injection is the inhibition of cytochrome P-450, which is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromise.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 29, 2023

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    04

    Endo International

    Ireland
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    Endo International

    Ireland
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Endo Launches First Generic Version of Noxafil (posaconazole) Injection

    Details : Posaconazole injection is the inhibition of cytochrome P-450, which is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromise.

    Brand Name : Noxafil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 29, 2023

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    Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

    Details:

    Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 03, 2023

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    05

    Endo Pharm

    Ireland
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    Endo Pharm

    Ireland
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

    Details : Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal...

    Brand Name : Noxafil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 03, 2023

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    Sumitomo Dainippon Pharma Oncology Announces First Patient Dosed in Phase 1/2 Study of DSP-5336 in Patients with Acute Leukemia With and Without Mixed L...

    Details:

    The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D).


    Lead Product(s): Enzomenib,Posaconazole

    Therapeutic Area: Oncology Brand Name: DSP-5336

    Study Phase: Phase I/ Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 29, 2022

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    06

    Sumitomo Pharma Oncology

    U.S.A
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    Not Confirmed

    Sumitomo Pharma Oncology

    U.S.A
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    Lead Product(s) : Enzomenib,Posaconazole

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sumitomo Dainippon Pharma Oncology Announces First Patient Dosed in Phase 1/2 Study of DSP-5336 in...

    Details : The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D).

    Brand Name : DSP-5336

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 29, 2022

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    Cadila Pharma Launches Triazole Antifungal Drug Posaconazole

    Details:

    Posaconazole is approved for prophylaxis against Aspergillus and Candida infections in immunocompromised patients at high risk for these infections and oropharyngeal candidiasis.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Posacad

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 01, 2021

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    07

    Cadila Pharmaceuticals

    India
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    Not Confirmed

    Cadila Pharmaceuticals

    India
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Cadila Pharma Launches Triazole Antifungal Drug Posaconazole

    Details : Posaconazole is approved for prophylaxis against Aspergillus and Candida infections in immunocompromised patients at high risk for these infections and oropharyngeal candidiasis.

    Brand Name : Posacad

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 01, 2021

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    Mankind Pharma Launches Drug to Treat Black Fungus

    Details:

    Posaconazole has been found to be a safer and effective drug of choice for the management of the disease. The drug has received approval from the Drug Controller General of India (DCGI).


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 10, 2021

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    08

    Mankind Pharma

    India
    arrow
    Duphat
    Not Confirmed

    Mankind Pharma

    India
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    Duphat
    Not Confirmed
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Mankind Pharma Launches Drug to Treat Black Fungus

    Details : Posaconazole has been found to be a safer and effective drug of choice for the management of the disease. The drug has received approval from the Drug Controller General of India (DCGI).

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 10, 2021

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    Bajaj Healthcare Launches Posaconazole API for Treatment of Black Fungus Infection

    Details:

    Posaconazole is a triazole antifungal agent indicated for treating Mucormycosis patients popularly known as Black Fungus in post Covid complications.


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 28, 2021

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    09

    Bajaj Healthcare

    India
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    Not Confirmed

    Bajaj Healthcare

    India
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    Duphat
    Not Confirmed
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Bajaj Healthcare Launches Posaconazole API for Treatment of Black Fungus Infection

    Details : Posaconazole is a triazole antifungal agent indicated for treating Mucormycosis patients popularly known as Black Fungus in post Covid complications.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 28, 2021

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    MSN Labs Launch Indigenous Drug Posaconazole to Treat Black Fungus

    Details:

    Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: PosaOne

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 22, 2021

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    10

    MSN Laboratories

    India
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    Duphat
    Not Confirmed

    MSN Laboratories

    India
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    Duphat
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    MSN Labs Launch Indigenous Drug Posaconazole to Treat Black Fungus

    Details : Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).

    Brand Name : PosaOne

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 22, 2021

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    01

    Sanofi

    France
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    PharmaVenue
    Not Confirmed
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
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    Regulatory Info :

    Registration Country : Switzerland

    Posaconazole

    Brand Name : Posaconazole Zentiva

    Dosage Form : Tabl

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

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    02

    Sanofi

    France
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    PharmaVenue
    Not Confirmed
    • fda
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Switzerland

    Posaconazole

    Brand Name : Posaconazole Zentiva

    Dosage Form : Tabl

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

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    03

    Cohance Lifesciences

    India
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    PharmaVenue
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    04

    Cohance Lifesciences

    India
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    PharmaVenue
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Granules

    Dosage Strength : 16.39%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    05

    Cohance Lifesciences

    India
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    PharmaVenue
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Delayed Release Pellet

    Dosage Strength : 16.39%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

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    06

    Dr. Reddy's Laboratories

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info : RX

    Registration Country : USA

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2022-04-07

    Application Number : 212500

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    07

    Dr. Reddy's Laboratories

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Oral Solid Dosage Form

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Dr Reddy Company Banner

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    08

    Alfred E Tiefenbacher GmbH

    Germany
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    Not Confirmed
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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Flag Germany
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    Regulatory Info : RX

    Registration Country : USA

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2021-02-01

    Application Number : 213454

    Regulatory Info : RX

    Registration Country : USA

    Tiefenbacher Compnay Banner

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    09

    Alfred E Tiefenbacher GmbH

    Germany
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    PharmaVenue
    Not Confirmed
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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Posaconazole

    Brand Name :

    Dosage Form : Gastro Retentive Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Tiefenbacher Compnay Banner

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    10

    Alfred E Tiefenbacher GmbH

    Germany
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    PharmaVenue
    Not Confirmed
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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Flag Germany
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    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Posaconazole

    Brand Name :

    Dosage Form : Gastro Retentive Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Tiefenbacher Compnay Banner

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    DR REDDYS

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
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    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Approval Date : 2022-04-07

    Application Number : 212500

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Dr Reddy Company Banner

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    02

    AET PHARMA

    Germany
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    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Approval Date : 2021-02-01

    Application Number : 213454

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Tiefenbacher Compnay Banner

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    03

    AMNEAL

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
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    AMNEAL

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Approval Date : 2022-12-22

    Application Number : 216626

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    SCHERING

    Germany
    BIO Partnering at JPM
    Not Confirmed
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    SCHERING

    Germany
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    BIO Partnering at JPM
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    POSACONAZOLE

    Brand Name : NOXAFIL

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 40MG/ML

    Approval Date : 2006-09-15

    Application Number : 22003

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    05

    SCHERING

    Germany
    BIO Partnering at JPM
    Not Confirmed
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    SCHERING

    Germany
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    BIO Partnering at JPM
    Not Confirmed
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    RLD :

    TE Code :

    POSACONAZOLE

    Brand Name : NOXAFIL

    Dosage Form : SUSPENSION; ORAL

    Dosage Strength : 40MG/ML

    Approval Date :

    Application Number : 22027

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    FRESENIUS KABI USA

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FRESENIUS KABI USA

    U.S.A
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code : AP

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 300MG/16.7ML (18MG/ML)

    Approval Date : 2023-12-26

    Application Number : 209983

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    07

    HIKMA

    United Kingdom
    BIO Partnering at JPM
    Not Confirmed
    arrow

    HIKMA

    United Kingdom
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 40MG/ML

    Approval Date : 2020-05-15

    Application Number : 208773

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    I 3 PHARMS

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
    arrow

    I 3 PHARMS

    U.S.A
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Approval Date : 2023-08-28

    Application Number : 216488

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    SPECGX LLC

    Ireland
    BIO Partnering at JPM
    Not Confirmed
    arrow

    SPECGX LLC

    Ireland
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Ireland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 100MG

    Approval Date : 2022-05-10

    Application Number : 212226

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    MYLAN LABS LTD

    U.S.A
    BIO Partnering at JPM
    Not Confirmed
    arrow

    MYLAN LABS LTD

    U.S.A
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AP

    POSACONAZOLE

    Brand Name : POSACONAZOLE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 300MG/16.7ML (18MG/ML)

    Approval Date : 2023-12-26

    Application Number : 211500

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Europe

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    01

    Helvepharm AG

    France
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Switzerland

    Posaconazole

    Brand Name : Posaconazole Zentiva

    Dosage Form : Tabl

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Helvepharm AG

    France
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Switzerland

    Posaconazole

    Brand Name : Posaconazole Zentiva

    Dosage Form : Tabl

    Dosage Strength : 100mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

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    Digital Content

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    03

    ALFRED E TIEFENBACHER GmbH & Co KG

    Germany
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Flag Germany
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Posaconazole

    Brand Name :

    Dosage Form : Gastro Retentive Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Status- Under Registration

    Registration Country : Germany

    Tiefenbacher Compnay Banner

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    04

    ACCORD HEALTHCARE SLU

    United Kingdom
    Duphat
    Not Confirmed
    arrow

    ACCORD HEALTHCARE SLU

    United Kingdom
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag United Kingdom
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Brand Name : POSACONAZOLE ACCORD

    Dosage Form : Gastro-Resistant Tablet Oral Use Blister

    Dosage Strength : 100 mg

    Packaging : 24 UNITS 100 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    FRESENIUS KABI ITALIA SRL

    Germany
    Duphat
    Not Confirmed
    arrow

    FRESENIUS KABI ITALIA SRL

    Germany
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Germany
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Brand Name : POSACONAZOLE FRESENIUS KABI

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 24 UNITS 100 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    06

    Merck Sharp & Dohme Limited

    U.S.A
    Duphat
    Not Confirmed
    arrow

    Merck Sharp & Dohme Limited

    U.S.A
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    posaconazole

    Brand Name : Noxafil

    Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION

    Dosage Strength : 300 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    07

    MERCK SHARP & DOHME Ltd

    U.S.A
    Duphat
    Not Confirmed
    arrow

    MERCK SHARP & DOHME Ltd

    U.S.A
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Brand Name : Noxafil

    Dosage Form : Posaconazolo 100Mg 24 Units Of Oral Use

    Dosage Strength : 24 cpr gastrores 100 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Digital Content

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    08

    TEVA BV

    Israel
    Duphat
    Not Confirmed
    arrow

    TEVA BV

    Israel
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Brand Name : POSACONAZOLE TEVA

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 24 UNITS 100 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    09

    MYLAN SPA

    U.S.A
    Duphat
    Not Confirmed
    arrow

    MYLAN SPA

    U.S.A
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Brand Name : POSACONAZOLE MYLAN PHARMA

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 24 UNITS 100 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Viatris Pharma GmbH

    U.S.A
    Duphat
    Not Confirmed
    arrow

    Viatris Pharma GmbH

    U.S.A
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Switzerland

    Posaconazole

    Brand Name : Posaconazole Mylan

    Dosage Form : Susp

    Dosage Strength : 40mg/ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Website

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    Canada

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    01

    GLENMARK PHARMACEUTICALS CANADA INC.

    India
    PharmaVenue
    Not Confirmed
    arrow

    GLENMARK PHARMACEUTICALS CANADA INC.

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : GLN-POSACONAZOLE

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2542021

    Regulatory Info :

    Registration Country : Canada

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    02

    JAMP PHARMA CORPORATION

    Canada
    PharmaVenue
    Not Confirmed
    arrow

    JAMP PHARMA CORPORATION

    Canada
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Canada
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : JAMP POSACONAZOLE

    Dosage Form : SUSPENSION

    Dosage Strength : 40MG/ML

    Packaging :

    Approval Date :

    Application Number : 2530333

    Regulatory Info :

    Registration Country : Canada

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    03

    MERCK CANADA INC

    Canada
    PharmaVenue
    Not Confirmed
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    MERCK CANADA INC

    Canada
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Canada
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : POSANOL

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 100MG

    Packaging : 60

    Approval Date :

    Application Number : 2424622

    Regulatory Info :

    Registration Country : Canada

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    04

    MERCK CANADA INC

    Canada
    PharmaVenue
    Not Confirmed
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    MERCK CANADA INC

    Canada
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    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : POSANOL

    Dosage Form : SOLUTION

    Dosage Strength : 300MG/16.7ML

    Packaging : 16.7ML

    Approval Date :

    Application Number : 2432676

    Regulatory Info :

    Registration Country : Canada

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    05

    MERCK CANADA INC

    Canada
    PharmaVenue
    Not Confirmed
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    MERCK CANADA INC

    Canada
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    PharmaVenue
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : POSANOL

    Dosage Form : SUSPENSION

    Dosage Strength : 200MG/5ML

    Packaging : 105ML

    Approval Date :

    Application Number : 2293404

    Regulatory Info :

    Registration Country : Canada

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    06

    MINT PHARMACEUTICALS INC

    Canada
    PharmaVenue
    Not Confirmed
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    MINT PHARMACEUTICALS INC

    Canada
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : MINT-POSACONAZOLE

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2544644

    Regulatory Info :

    Registration Country : Canada

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    07

    SANDOZ CANADA INCORPORATED

    Switzerland
    PharmaVenue
    Not Confirmed
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    SANDOZ CANADA INCORPORATED

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : SANDOZ POSACONAZOLE

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2496259

    Regulatory Info :

    Registration Country : Canada

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    08

    TARO PHARMACEUTICALS INC

    U.S.A
    PharmaVenue
    Not Confirmed
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    TARO PHARMACEUTICALS INC

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info :

    Registration Country : Canada

    POSACONAZOLE

    Brand Name : TARO-POSACONAZOLE

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2543311

    Regulatory Info :

    Registration Country : Canada

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    Listed Dossiers

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    01

    Cohance Lifesciences

    India
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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    01

    Cohance Lifesciences

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Posaconazole

    Dosage : Tablet

    Dosage Strength : 100MG

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

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    02

    Cohance Lifesciences

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Posaconazole

    Brand Name :

    Dosage Form : Granules

    Dosage Strength : 16.39%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

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    02

    Cohance Lifesciences

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Posaconazole

    Dosage : Granules

    Dosage Strength : 16.39%

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    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

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    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Posaconazole

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    Dosage Form : Delayed Release Pellet

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    Approval Date :

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    Regulatory Info :

    Registration Country : India

    Cohance

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Posaconazole

    Dosage : Delayed Release Pellet

    Dosage Strength : 16.39%

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    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

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    Dr. Reddy's Laboratories

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info : Lead Market Dossiers- Filed

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    Posaconazole

    Brand Name :

    Dosage Form : Oral Solid Dosage Form

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Dr Reddy Company Banner

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    Dr. Reddy's Laboratories

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info : Lead Market Dossiers- Filed

    Posaconazole

    Dosage : Oral Solid Dosage Form

    Dosage Strength : 100MG

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    Approval Date :

    Application Number :

    Registration Country : India

    Dr Reddy Company Banner

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    ALFRED E TIEFENBACHER GmbH & Co KG

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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Regulatory Info : Status- Under Registration

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    Posaconazole

    Brand Name :

    Dosage Form : Gastro Retentive Table...

    Dosage Strength : 100MG

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    Approval Date :

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    Regulatory Info : Status- Under Registration

    Registration Country : Germany

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    ALFRED E TIEFENBACHER GmbH & Co KG

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    Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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    Posaconazole

    Dosage : Gastro Retentive Table...

    Dosage Strength : 100MG

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    Approval Date :

    Application Number :

    Registration Country : Germany

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    NanoAlvand

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    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Posaconazole

    Brand Name : Pixana

    Dosage Form : Vial

    Dosage Strength : 300MG/16.7ML

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    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    NanoAlvand

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    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Posaconazole

    Dosage : Vial

    Dosage Strength : 300MG/16.7ML

    Brand Name : Pixana

    Approval Date :

    Application Number :

    Registration Country : Iran

    NanoAlvand

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    07

    Farmatek

    Turkey
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    Posaconazole

    Brand Name :

    Dosage Form : Oral Suspension

    Dosage Strength : 40MG/ML

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    Approval Date :

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    Regulatory Info :

    Registration Country : Turkey

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    Farmatek

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    Posaconazole

    Dosage : Oral Suspension

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    Approval Date :

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    Registration Country : Turkey

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    08

    Hainan Poly Pharm Co. Ltd

    China
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    Hainan Poly Pharm Co. Ltd

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    Posaconazole

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    Dosage Form : Injection

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    Hainan Poly Pharm Co. Ltd

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    Posaconazole

    Dosage : Injection

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    Registration Country : China

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    Hainan Poly Pharm Co. Ltd

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    Regulatory Info :

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    Posaconazole

    Brand Name :

    Dosage Form : Oral Suspension

    Dosage Strength : 40MG/ML

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    Hainan Poly Pharm Co. Ltd

    China
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    Hainan Poly Pharm Co. Ltd

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    Packaging :

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    Posaconazole

    Dosage : Oral Suspension

    Dosage Strength : 40MG/ML

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    Approval Date :

    Application Number :

    Registration Country : China

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    10

    Health Biotech

    India
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    Health Biotech

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    Posaconazole

    Brand Name :

    Dosage Form : Injection

    Dosage Strength : 100MG

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    Regulatory Info :

    Registration Country : India

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    Health Biotech

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    ABOUT THIS PAGE

    Posaconazole Manufacturers

    A Posaconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Posaconazole, including repackagers and relabelers. The FDA regulates Posaconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Posaconazole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Posaconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Posaconazole Suppliers

    A Posaconazole supplier is an individual or a company that provides Posaconazole active pharmaceutical ingredient (API) or Posaconazole finished formulations upon request. The Posaconazole suppliers may include Posaconazole API manufacturers, exporters, distributors and traders.

    click here to find a list of Posaconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Posaconazole USDMF

    A Posaconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Posaconazole active pharmaceutical ingredient (API) in detail. Different forms of Posaconazole DMFs exist exist since differing nations have different regulations, such as Posaconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Posaconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Posaconazole USDMF includes data on Posaconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Posaconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Posaconazole suppliers with USDMF on PharmaCompass.

    Posaconazole KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Posaconazole Drug Master File in Korea (Posaconazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Posaconazole. The MFDS reviews the Posaconazole KDMF as part of the drug registration process and uses the information provided in the Posaconazole KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Posaconazole KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Posaconazole API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Posaconazole suppliers with KDMF on PharmaCompass.

    Posaconazole WC

    A Posaconazole written confirmation (Posaconazole WC) is an official document issued by a regulatory agency to a Posaconazole manufacturer, verifying that the manufacturing facility of a Posaconazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Posaconazole APIs or Posaconazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Posaconazole WC (written confirmation) as part of the regulatory process.

    click here to find a list of Posaconazole suppliers with Written Confirmation (WC) on PharmaCompass.

    Posaconazole NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Posaconazole as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Posaconazole API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Posaconazole as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Posaconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Posaconazole NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Posaconazole suppliers with NDC on PharmaCompass.

    Posaconazole GMP

    Posaconazole Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Posaconazole GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Posaconazole GMP manufacturer or Posaconazole GMP API supplier for your needs.

    Posaconazole CoA

    A Posaconazole CoA (Certificate of Analysis) is a formal document that attests to Posaconazole's compliance with Posaconazole specifications and serves as a tool for batch-level quality control.

    Posaconazole CoA mostly includes findings from lab analyses of a specific batch. For each Posaconazole CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Posaconazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Posaconazole EP), Posaconazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Posaconazole USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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