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    Also known as: Cialis, 171596-29-5, Ic351, Tadanafil, Adcirca, Ic 351
    Molecular Formula
    C22H19N3O4
    Molecular Weight
    389.4  g/mol
    InChI Key
    WOXKDUGGOYFFRN-IIBYNOLFSA-N
    FDA UNII
    742SXX0ICT
    Tadalafil
    A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.
    Tadalafil is a Phosphodiesterase 5 Inhibitor. The mechanism of action of tadalafil is as a Phosphodiesterase 5 Inhibitor.
    1 2D Structure

    Tadalafil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,8R)-2-(1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione
    2.1.2 InChI
    InChI=1S/C22H19N3O4/c1-24-10-19(26)25-16(22(24)27)9-14-13-4-2-3-5-15(13)23-20(14)21(25)12-6-7-17-18(8-12)29-11-28-17/h2-8,16,21,23H,9-11H2,1H3/t16-,21-/m1/s1
    2.1.3 InChI Key
    WOXKDUGGOYFFRN-IIBYNOLFSA-N
    2.1.4 Canonical SMILES
    CN1CC(=O)N2C(C1=O)CC3=C(C2C4=CC5=C(C=C4)OCO5)NC6=CC=CC=C36
    2.1.5 Isomeric SMILES
    CN1CC(=O)N2[C@@H](C1=O)CC3=C([C@H]2C4=CC5=C(C=C4)OCO5)NC6=CC=CC=C36
    2.2 Other Identifiers
    2.2.1 UNII
    742SXX0ICT
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Cialis

    2. Ic 351

    3. Ic-351

    4. Ic351

    5. Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3- Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6r,12ar)-

    2.3.2 Depositor-Supplied Synonyms

    1. Cialis

    2. 171596-29-5

    3. Ic351

    4. Tadanafil

    5. Adcirca

    6. Ic 351

    7. Icos 351

    8. Ic-351

    9. Gf 196960

    10. (6r,12ar)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,12,12a-tetrahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4(6h,7h)-dione

    11. Tadalafil Mylan

    12. Trans-tadalafil

    13. Tadalafil(cialis)

    14. (6r,12ar)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

    15. (6r-trans)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

    16. Chembl779

    17. Nsc-750236

    18. Nsc-759172

    19. 742sxx0ict

    20. Gf-196960

    21. Ly-450190

    22. (6r,12ar)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    23. Chebi:71940

    24. Tadalafil [usan]

    25. Ly450190

    26. Dsstox_cid_26786

    27. Dsstox_rid_81904

    28. Dsstox_gsid_46786

    29. (6r,12ar)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    30. 6-benzo[1,3]dioxol-5-yl-2-methyl-2,3,6,7,12,12a-hexahydro-pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    31. Tadalafil Lilly

    32. Smr000466321

    33. Cialis (tn)

    34. Tildenafil

    35. Cas-171596-29-5

    36. Hsdb 7303

    37. Unii-742sxx0ict

    38. Tadalafila

    39. Tadalafilo

    40. Taldalafil

    41. Tadalafil [usan:inn:ban]

    42. Tadalafil Solution

    43. 1xoz

    44. Cialis, Tadalafil

    45. Ncgc00168781-01

    46. Tadalafil- Bio-x

    47. (2r,8r)-2-(1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione

    48. Adcirca (tn)

    49. Tadalafil (cialis)

    50. Zalutia (tn)

    51. (6r,12ar)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

    52. Ks-1117

    53. Tadalafil [inn]

    54. Tadalafil [jan]

    55. Tadalafil [mi]

    56. Tadalafil; Cialis

    57. Tadalafil [hsdb]

    58. Tadalafil [vandf]

    59. (-)-tadalafil (6r)

    60. Tadalafil [mart.]

    61. Tadalafil [usp-rs]

    62. Tadalafil [who-dd]

    63. Tadalafil (jan/usp/inn)

    64. Schembl33333

    65. Tadalafil [ema Epar]

    66. Mls000759426

    67. Mls001165782

    68. Mls001195644

    69. Mls001424132

    70. Mls006010126

    71. Tadalafil Specified Impurity A

    72. Gtpl7299

    73. Tadalafil [orange Book]

    74. Dtxsid9046786

    75. Tadalafil [ep Monograph]

    76. Bdbm14777

    77. Tadalafil (6r ,12as)- Lilly

    78. Tadalafil [usp Monograph]

    79. Entadfi Component Tadalafil

    80. Hms2051n17

    81. Hms2235l21

    82. Hms3884g19

    83. Pharmakon1600-01505639

    84. Amy10321

    85. Ex-a2644

    86. Zinc3993855

    87. Tox21_112642

    88. Hy-90009a

    89. Mfcd07771966

    90. Nsc750236

    91. Nsc759172

    92. S1512

    93. Tadalafil 1.0 Mg/ml In Acetonitrile

    94. Tadalafil 100 Microg/ml In Methanol

    95. Tadalafil Component Of Entadfi

    96. Akos015892559

    97. Tox21_112642_1

    98. Ab42193

    99. Ccg-100973

    100. Cs-1414

    101. Db00820

    102. Nc00223

    103. Nsc 750236

    104. Nsc 759172

    105. 1,3-benzodioxol-5-yl(methyl)[?]dione

    106. Ncgc00263909-02

    107. Tadalafil 100 Microg/ml In Acetonitrile

    108. (6r,12ar)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    109. Bt164435

    110. Gf196960

    111. Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6r,12ar)-

    112. Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6r-trans)-

    113. (-)-tadalafil (6r ,12as) Diastereomer

    114. Sw197603-2

    115. A23556

    116. D02008

    117. Ab00639969-08

    118. Ab00639969_09

    119. Ab00639969_10

    120. 596t295

    121. Ar-270/43507798

    122. Q424156

    123. Sr-05000001940

    124. Sr-05000001940-1

    125. Brd-k93645900-001-04-8

    126. Tadalafil Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    127. (2r,8r)-2-(1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione

    128. (2r,8r)-2-(2h-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11(16),12,14-tetraene-4,7-dione

    129. (2r,8r)-2-(2h-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione

    130. (6r,12 Ar)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    131. (6r,12ar) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino [1',2':1,6] Pyrido[3,4-b]indole-1,4-dione

    132. (6r,12ar) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    133. (6r,12ar)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1,2:1,6]pyrido[3,4-b]indole-1,4-dione

    134. (6r,12ar)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1,2,1,6]pyrido[3,4-b]indole-1,4-dione

    135. (6r,3,6,7,12,12a-hexahydro-2-methyl-6-[3,4-(methylenedioxy)phenyl]pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

    136. 1242099-07-5

    137. 171488-03-2

    138. 6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[2',1':6,1]pyrido[3,4-b]indole-1,4-dione

    139. Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6r-12ar)-

    140. Pyrazino[1',6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12ahexahydro-2-methyl-, (6r,12ar)-

    141. Rel-(6r,12ar)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,12,12a-tetrahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4(6h,7h)-dione

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 389.4 g/mol
    Molecular Formula C22H19N3O4
    XLogP32.3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count1
    Exact Mass389.13755610 g/mol
    Monoisotopic Mass389.13755610 g/mol
    Topological Polar Surface Area74.9 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity702
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 6  
    Drug NameAdcirca
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a mo...
    Active IngredientTadalafil
    Dosage FormTablet
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyEli Lilly

    2 of 6  
    Drug NameCialis
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelCIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is: The ch...
    Active IngredientTadalafil
    Dosage FormTablet
    RouteOral
    Strength2.5mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    3 of 6  
    Drug NameTadalafil
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelCIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is: The ch...
    Active IngredientTadalafil
    Dosage FormTablet
    Routeoral
    Strength20mg
    Market StatusTentative Approval
    CompanySynthon Pharms

    4 of 6  
    Drug NameAdcirca
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a mo...
    Active IngredientTadalafil
    Dosage FormTablet
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyEli Lilly

    5 of 6  
    Drug NameCialis
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelCIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is: The ch...
    Active IngredientTadalafil
    Dosage FormTablet
    RouteOral
    Strength2.5mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    6 of 6  
    Drug NameTadalafil
    PubMed HealthTadalafil (By mouth)
    Drug ClassesAntihypertensive, Erectile Dysfunction Agent
    Drug LabelCIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is: The ch...
    Active IngredientTadalafil
    Dosage FormTablet
    Routeoral
    Strength20mg
    Market StatusTentative Approval
    CompanySynthon Pharms

    4.2 Therapeutic Uses

    Tadalafil is indicated for the treatment of erectile dysfunction. /Included in US product labeling/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    4.3 Drug Warning

    The Food and Drug Administration ... approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.

    US FDA; FDA Statement. FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems (July 8, 2005) Available from, as of July 12, 2005: https://www.fda.gov/bbs/topics/NEWS/2005/NEW01201.html

    Cardiovascular status of patients should be considered since there is a degree of risk associated with sexual activity; treatments for erectile dysfunction, including tadalafil, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiac status.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Cialis, and, therefore, the use of Cialis is not recommended in these groups until further information is available: patients with a myocardial infarction within the last 90 days, patients with unstable angina or angina occurring during sexual intercourse, patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg), and patients with a stroke within the last 6 months. In addition, patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004.

    The effect of a 100 mg single dose of tadalafil on the QT interval was evaluated at the time of peak tadalafil concentration in a randomized, double-blinded, placebo, and active (intravenous ibutilide)-controlled crossover study in 90 healthy males aged 18 to 53 years. The mean change in QTc (Fridericia QT correction) for tadalafil, relative to placebo, was 3.5 milliseconds (two-sided 90% CI=1.9, 5.1). The mean change in QTc (Individual QT correction) for tadalafil, relative to placebo, was 2.8 milliseconds (two-sided 90% CI=1.2, 4.4). A 100 mg dose of tadalafil (5 times the highest recommended dose) was chosen because this dose yields exposures covering those observed upon coadministration of tadalafil with potent CYP3A4 inhibitors or those observed in renal impairment. In this study, the mean increase in heart rate associated with /this/ dose of tadalafil compared to placebo was 3.1 beats per minute.

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004.

    For more Drug Warnings (Complete) data for TADALAFIL (18 total), please visit the HSDB record page.

    4.4 Drug Indication

    Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with [finasteride] for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with [macitentan] or other endothelin-1 antagonists.

    FDA Label

    Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5. 1).

    Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

    Treatment of erectile dysfunction.

    In order for tadalafil to be effective, sexual stimulation is required.

    Cialis is not indicated for use by women.

    Treatment of erectile dysfunction in adult males.

    In order for tadalafil to be effective, sexual stimulation is required.

    Tadalafil Lilly is not indicated for use by women.

    Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

    Treatment of erectile dysfunction in adult males.

    In order for tadalafil to be effective, sexual stimulation is required.

    Tadalafil Mylan is not indicated for use by women.

    Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

    Treatment of pulmonary arterial hypertension

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Tadalafil exerts a therapeutic effect in ED by increasing sexual stimulation-dependant smooth muscle relaxation in the penis, allowing the corpus cavernosum to fill with blood to produce an erection. Smooth muscle relaxation in the pulmonary vasculature helps to produce vasodilation in PAH which reduces blood pressure in the pulmonary arteries. In BPH, tadalafil may contribute to decreased smooth muscle cell proliferation which may reduce the size of the prostate and relieve the anatomical obstruction which produces urinary symptoms of BPH. The decreased affinity of tadalafil for PDE6 compared to other PDE5 inhibitors may explain the reduced incidence of visual side effects.

    5.2 MeSH Pharmacological Classification

    Vasodilator Agents

    Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

    Phosphodiesterase 5 Inhibitors

    Compounds that specifically inhibit PHOSPHODIESTERASE 5. (See all compounds classified as Phosphodiesterase 5 Inhibitors.)

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TADALAFIL
    5.3.2 FDA UNII
    742SXX0ICT
    5.3.3 Pharmacological Classes
    Phosphodiesterase 5 Inhibitors [MoA]; Phosphodiesterase 5 Inhibitor [EPC]
    5.4 ATC Code

    G04BE08

    G04BE08

    G04BE08

    G04BE08

    G04BE08

    G04BE08

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    G - Genito urinary system and sex hormones

    G04 - Urologicals

    G04B - Urologicals

    G04BE - Drugs used in erectile dysfunction

    G04BE08 - Tadalafil

    5.5 Absorption, Distribution and Excretion

    Absorption

    Tadalafil has a tmax of 0.5-6h with a median of 2h in healthy adults. The tmax in adults with PAH is reported as 2-8h with a median of 4h. There does not appear to be a significant effect on absorption when tadalafil is taken with food.

    Route of Elimination

    Tadalafil is primarily eliminated via hepatic metabolism. These metabolites are mainly excreted in the feces (61%) and to a lesser extent in the urine (36%)

    Volume of Distribution

    Tadalafil has a mean apparent volume of distribution of 63L in healthy adults. The mean apparent volume of distribution is reported as 77L in adults with PAH.

    Clearance

    The mean apparent oral clearance of tadalafil is 2.5-3.4L/h in healthy adults. The mean apparent oral clearance in adults with PAH is reported as 3.5L/h

    Tmax: 30 minutes to 6 hours (median 2 hours). Absolute bioavailability has not been determined; rate and extent of absorption are not influenced by food.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    Volume of distribution: 63 L; indicating distribution into tissues. Less than 0.0005% of administered dose was found in the semen of healthy subjects. 94% protein bound.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects. Steady-state plasma concentrations are attained within 5 days of once-daily dosing, and exposure is approximately 1.6-fold greater than after a single dose.

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004.

    Elimination: Mean oral clearance: 2.5 L per hour. Fecal: 61%. Urine: 36%.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    For more Absorption, Distribution and Excretion (Complete) data for TADALAFIL (11 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Tadalafil undergoes hepatic metabolism via CYP3A4 to a catechol metabolite. This catechol metabolite undergoes subsequent methylation and glucuronidation with the methyl-glucuronide metabolite becoming the primary metabolite in circulation. None of the known metabolites are considered to be active.

    Biotransformation: Hepatic metabolism, mainly by CYP3A4. Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite. The catechol metabolite undergoes extensive methylation and glucuronidation to form the methylcatechol and methylcatechol glucuronide conjugate, respectively. The major circulating metabolite is the methylcatechol glucuronide. Methylcatechol concentrations are less than 10% of glucuronide concentrations. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    5.7 Biological Half-Life

    The mean half-life of elimination of tadalafil is 15-17.5h in healthy adults. The mean half-life of elimination in adults with PAH is reported as 35h.

    Terminal: 17.5 hours

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    5.8 Mechanism of Action

    Tadalafil is a selective phosphodiesterase-5 (PDE5) inhibitor that produces several downstream effects with the most common therapeutic effect being smooth muscle relaxation. Patients may experience ED due to a variety of causes including psychogenic, neurogenic, vasculogenic, iatrogenic, or endocrine. These causes result in dysfunction of penile smooth muscle relaxation through either disrupted neuronal signaling or direct influence on smooth muscle cells. During sexual arousal, non-adrenergic non-cholinergic (NANC) neurons release nitric oxide (NO). Nitric oxide stimulates guanylate cyclase which converts guanosine triphosphate to cyclic guanosine monophosphate (cGMP). cGMP activates the cGMP-dependent kinase (PKG) in a signal cascade which activates K+ channels leading to inhibition of Ca2+ channels, inhibits platelet activation, and inhibits smooth muscle cell proliferation while inducing apoptosis. This signal cascade is attenuated by PDE5 which breaks the phosphodiester bond of cGMP, converting it to GMP. Inhibition of PDE5 by tadalafil increases signaling via the PKG cascade which supports penile smooth muscle relaxation during sexual arousal by decreasing Ca2+ entry into smooth muscle cells. This smooth muscle relaxation allows blood to fill the corpus cavernosum thereby producing an erection. In PAH, blood pressure in the pulmonary arteries is raised due to a variety of mechanisms stemming from endothelial dysfunction. Decreased production of NO and prostacyclin reduce vasodilatory signaling while overproduction of endothelin-1 and thromboxane increase vasoconstriction. Inflammation, thromboses, and hypoxia later contribute to vascular remodeling which further reduces luminal size. The resultant increase in blood pressure reduces the capacity for gas exchange and increases afterload at the right ventricle, producing symptoms of dyspnea, fatigue, and dizziness as well as leading to right-sided heart failure. Tadalafil exerts its therapeutic effect in PAH through boosting NO-cGMP signaling to contribute to smooth muscle relaxation as with ED. Lastly, tadalafil is used to treat BPH. BPH produces urinary dysfunction through hyperproliferation of the epithelial and smooth muscle layers of the prostate. The increased size of the prostate blocks urine flow through the urethra resulting in higher residual volumes due to incomplete emptying. Tadalafil does not appear to exert its benefit via smooth muscle relaxation of the prostate. It may instead exert its effect through a mix of increased oxygenation and decreased inflammation, which decreases tissue remodeling, and inhibition of cell proliferation through the cGMP cascade. The decreased affinity for PDE6 compared to other PDE5 inhibitors may explain the decreased incidence of visual side effects as PDE6 is present in the eye and contributes to color vision.

    In vitro studies have shown that the effect of tadalafil is more potent on phosphodiesterase type 5 (PDE5) than on other phosphodiesterases. These studies have shown that tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Additionally, tadalafil is 700-fold more potent for PDE5 than for PDE8, PDE9, PDE10 and 14-fold more potent for PDE5 than for PDE11A1, an enzyme found in human skeletal muscle. Tadalafil inhibits human recombinant PDE11A1 activity at concentrations within the therapeutic range. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    Studies in vitro have demonstrated that tadalafil is a selective inhibitor of phosphodiesterase type 5 (PDE5). PDE5 is found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

    Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosum smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cyclic GMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect on the absence of sexual stimulation.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004.

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        SHANDONG ANXIN PHARMACEUTICAL CO., ...

        China
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        Tadalafil

        Certificate Number : R1-CEP 2016-001 - Rev 00

        Status : Valid

        Issue Date : 2022-02-02

        Type : Chemical

        Substance Number : 2606

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        Unichem Laboratories Limited Mumbai...

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        R1-CEP 2015-132 - Rev 00
        Valid
        Chemical
        2021-07-07
        2606
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        Unichem Laboratories Limited Mumbai...

        India
        Pharmtech & Ingredients
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        Unichem Laboratories Limited Mumbai...

        India
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        Tadalafil

        Certificate Number : R1-CEP 2015-132 - Rev 00

        Status : Valid

        Issue Date : 2021-07-07

        Type : Chemical

        Substance Number : 2606

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        Ami Lifesciences Private Limited

        India
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        Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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        Tadalafil Ph.Eur.lBP/USP

        Date of Issue : 2022-08-11

        Valid Till : 2025-06-26

        Written Confirmation Number : WC-0054

        Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...

        AMI Lifesciences

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        02

        Aurobindo Pharma Limited

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Aurobindo Pharma Limited

        India
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        Tadalafil (Ph.Eur.)

        Date of Issue : 2022-06-06

        Valid Till : 2025-06-10

        Written Confirmation Number : WC-0017

        Address of the Firm : Unit No. VIII, Sy. No. 10 & 13, Gaddapotharam Village, I,D.A. Kazipally, Jinnara...

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        03

        Glenmark Life Sciences

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Glenmark Life Sciences

        India
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        Tadalafil (USP/EP)

        Date of Issue : 2023-12-28

        Valid Till : 2026-12-28

        Written Confirmation Number : WC-0310

        Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase ll, Dahej, Dist-Bharuch, Gujarat

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        04

        Glenmark Life Sciences

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Glenmark Life Sciences

        India
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        Tadalafil EP

        Date of Issue : 2022-06-07

        Valid Till : 2025-06-25

        Written Confirmation Number : WC-0057n

        Address of the Firm : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat

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        05

        Macleods Pharmaceuticals Limited

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Macleods Pharmaceuticals Limited

        India
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        Tadalafil (Ph. Eur.)

        Date of Issue : 2019-11-28

        Valid Till : 2022-07-02

        Written Confirmation Number : WC-0079

        Address of the Firm : Plot No.2209, GIDC, Industrial Estate, At & Post Sarigam, Tal-Umbergaon, Valsad-...

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        06

        Phalanx Labs

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Phalanx Labs

        India
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        Tadalafil (USP/Ph.Eur/BP)

        Date of Issue : 2019-07-26

        Valid Till : 2022-07-25

        Written Confirmation Number : WC-0347

        Address of the Firm : Plot No.74B, Jawaharlal Nehru Pharma City,

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        07

        SMS Pharmaceuticals

        India
        Pharmtech & Ingredients
        Not Confirmed
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        SMS Pharmaceuticals

        India
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        Pharmtech & Ingredients
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        Tadalafil (USP/EP/IH)

        Date of Issue : 2019-06-26

        Valid Till : 2022-07-02

        Written Confirmation Number : WC-0071

        Address of the Firm : Unit-II, Plot No. 24 & 24 B, S. V. Co-Op. Indl. Estate, Bachupally Miyapur, R.R....

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        08

        Srini Pharmaceuticals

        India
        Pharmtech & Ingredients
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        Srini Pharmaceuticals

        India
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        Tadalafil USP/IH

        Date of Issue : 2019-05-21

        Valid Till : 2022-05-21

        Written Confirmation Number : WC-0313

        Address of the Firm : Survey No. 247, Choutuppal, Nalgonda Dist. 508252, Andhra Pradesh, india

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        09

        Sun Pharmaceutical Industries Limited

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Sun Pharmaceutical Industries Limited

        India
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        Tadalafil (USP/EP)

        Date of Issue : 2022-06-08

        Valid Till : 2025-07-25

        Written Confirmation Number : WC-0159

        Address of the Firm : A-7/A-8, MIDC, Ahmednagar-414 111, Maharashtra State

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        10

        Ultratech India Ltd.,

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Ultratech India Ltd.,

        India
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        Pharmtech & Ingredients
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        Tadalafil (EP/USP)

        Date of Issue : 2013-12-02

        Valid Till : 2016-11-21

        Written Confirmation Number : WC-257

        Address of the Firm : Plot No. 25-26, New Chemical Zone, MIDC Taloja, Dist Raigad-410208, Maharashtra

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        Evonik

        Germany
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        Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

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        Tadalafil

        Registrant Name : Korea Lily (U.S.)

        Registration Date : 2021-10-14

        Registration Number : 20211014-203-I-626-17

        Manufacturer Name : Evonik Corporation@Powdersiz...

        Manufacturer Address : Tippecanoe Laboratories, 1650 Lilly Road Lafayette, Indiana 47909, USA_x000D_ _x000D_...

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        02

        Ami Lifesciences Private Limited

        India
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        • fda
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        Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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        Tadalafil

        Registrant Name : Gapi Bio Co., Ltd.

        Registration Date : 2019-10-14

        Registration Number : 20191014-203-I-583-16

        Manufacturer Name : Ami Lifesciences Private Lim...

        Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

        AMI Lifesciences

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        03

        Pharmacostech

        South Korea
        Pharmtech & Ingredients
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        Pharmacostech

        South Korea
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        Tadalafil

        Registrant Name : Pharmacostec Co., Ltd.

        Registration Date : 2018-07-27

        Registration Number : 20180727-203-I-562-14

        Manufacturer Name : Pharmacostec Co., Ltd.

        Manufacturer Address : 47, Yakjedanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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        04

        Rakshit Drugs

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Rakshit Drugs

        India
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        Tadalafil

        Registrant Name : Ace Biopharm Co., Ltd.

        Registration Date : 2020-04-02

        Registration Number : 20170907-203-I-523-13(2)

        Manufacturer Name : Rakshit Pharmaceuticals Limi...

        Manufacturer Address : Plot No. 68/A, Jawaharlal Nehre Pharma City, E.Bonangi(v), Parawada Mandal, Visakhapa...

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        05

        Rakshit Drugs

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Rakshit Drugs

        India
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        Pharmtech & Ingredients
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        Tadalafil

        Registrant Name : Seoul Pharmaceutical Co., Ltd.

        Registration Date : 2019-09-17

        Registration Number : 20170907-203-I-523-13(1)

        Manufacturer Name : Rakshit Pharmaceuticals Limi...

        Manufacturer Address : Plot No. 68/A, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District, An...

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        06

        SMS Pharmaceuticals

        India
        Pharmtech & Ingredients
        Not Confirmed
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        SMS Pharmaceuticals

        India
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        Pharmtech & Ingredients
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        Tadalafil

        Registrant Name : Pami Future Co., Ltd.

        Registration Date : 2024-03-22

        Registration Number : 20240322-203-I-667-18

        Manufacturer Name : SMS Pharmaceuticals Limited ...

        Manufacturer Address : Unit-II, Plot No. 24 & 24B and 36 & 37, SV Co-Operative Industrial Estate, Bachupally...

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        07

        Viatris

        U.S.A
        Pharmtech & Ingredients
        Not Confirmed
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        Viatris

        U.S.A
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        Pharmtech & Ingredients
        Not Confirmed
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        Tadalafil

        Registrant Name : Ace Biopharm Co., Ltd.

        Registration Date : 2019-08-08

        Registration Number : 20190808-203-I-589-15

        Manufacturer Name : Tianish Laboratories Private...

        Manufacturer Address : Plot No.5, Road No.12 Tadi Village JN Pharma City, Parwada Mandal, Anakapalli Distric...

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        08

        Viatris

        U.S.A
        Pharmtech & Ingredients
        Not Confirmed
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        Viatris

        U.S.A
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        Pharmtech & Ingredients
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        Tadalafil

        Registrant Name : SK Pharmaceutical Co., Ltd.

        Registration Date : 2020-01-09

        Registration Number : 20190808-203-I-589-15(1)

        Manufacturer Name : Mylan Laboratories Limited (...

        Manufacturer Address : Plot No.5, Road No.12 Tadi Village JN Pharma City, Parwada Mandal, Visakhapatnam Dist...

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        09

        Zhejiang Huahai Pharmaceutical

        China
        Pharmtech & Ingredients
        Not Confirmed
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        Zhejiang Huahai Pharmaceutical

        China
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        Pharmtech & Ingredients
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        Tadalafil

        Registrant Name : Dongkwang Pharmaceutical Co., Ltd.

        Registration Date : 2019-11-20

        Registration Number : 20140829-203-I-455-10(5)

        Manufacturer Name : Zhejiang Huahai Pharmaceutic...

        Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

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        Zhejiang Huahai Pharmaceutical

        China
        Pharmtech & Ingredients
        Not Confirmed
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        Zhejiang Huahai Pharmaceutical

        China
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        Registrant Name : CMG Pharmaceutical Co., Ltd.

        Registration Date : 2018-11-26

        Registration Number : 20140829-203-I-455-10(4)

        Manufacturer Name : Zhejiang Huahai Pharmaceutic...

        Manufacturer Address : Chuannan Duqiao, Linhai, Zhejiang, 317016, China

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        Interquim, S.A.

        Spain
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        Pharmtech & Ingredients
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        Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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        TADALAFIL

        NDC Package Code : 64552-4047

        Start Marketing Date : 2008-01-07

        End Marketing Date : 2024-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

        Interquim

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        Evonik Corporation

        Germany
        arrow
        Pharmtech & Ingredients
        Not Confirmed
        • fda
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        Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

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        TADALAFIL

        NDC Package Code : 62128-0385

        Start Marketing Date : 2003-11-26

        End Marketing Date : 2024-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

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        03

        Aurobindo Pharma Limited

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Aurobindo Pharma Limited

        India
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        Not Confirmed
        • fda
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        TADALAFIL

        NDC Package Code : 65862-719

        Start Marketing Date : 2024-01-16

        End Marketing Date : 2025-12-31

        Dosage Form (Strength) : POWDER (50kg/50kg)

        Marketing Category : BULK INGREDIENT

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        04

        Azico Biophore India Private Limite...

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Azico Biophore India Private Limite...

        India
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        Pharmtech & Ingredients
        Not Confirmed
        • fda
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        TADALAFIL

        NDC Package Code : 69575-4051

        Start Marketing Date : 2024-03-08

        End Marketing Date : 2025-12-31

        Dosage Form (Strength) : POWDER (25kg/25kg)

        Marketing Category : BULK INGREDIENT

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        05

        Fagron Inc

        Netherlands
        Pharmtech & Ingredients
        Not Confirmed
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        Fagron Inc

        Netherlands
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        Pharmtech & Ingredients
        Not Confirmed
        • fda
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        TADALAFIL

        NDC Package Code : 51552-1550

        Start Marketing Date : 2017-12-06

        End Marketing Date : 2026-04-30

        Dosage Form (Strength) : POWDER (1g/g)

        Marketing Category : BULK INGREDIENT FOR HUMAN P...

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        06

        Galenova Inc

        Canada
        Pharmtech & Ingredients
        Not Confirmed
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        Galenova Inc

        Canada
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        • fda
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        TADALAFIL

        NDC Package Code : 79572-033

        Start Marketing Date : 2021-05-01

        End Marketing Date : 2025-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

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        07

        Maithili Life Sciences Private Limi...

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Maithili Life Sciences Private Limi...

        India
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        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
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        TADALAFIL

        NDC Package Code : 82053-003

        Start Marketing Date : 2022-05-10

        End Marketing Date : 2024-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

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        08

        QINGDAO TIDA BIOTEK CO.,LTD

        China
        Pharmtech & Ingredients
        Not Confirmed
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        QINGDAO TIDA BIOTEK CO.,LTD

        China
        arrow
        Pharmtech & Ingredients
        Not Confirmed
        • fda
        • EDQM
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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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        TADALAFIL

        NDC Package Code : 90027-004

        Start Marketing Date : 2020-11-18

        End Marketing Date : 2024-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT FOR HUMAN P...

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        09

        Srini Pharmaceuticals Private Limit...

        India
        Pharmtech & Ingredients
        Not Confirmed
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        Srini Pharmaceuticals Private Limit...

        India
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        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
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        TADALAFIL

        NDC Package Code : 66174-0021

        Start Marketing Date : 2015-03-24

        End Marketing Date : 2024-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

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        10

        Willow Birch Pharma, Inc

        U.S.A
        Pharmtech & Ingredients
        Not Confirmed
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        Willow Birch Pharma, Inc

        U.S.A
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        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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        TADALAFIL

        NDC Package Code : 10695-175

        Start Marketing Date : 2024-08-20

        End Marketing Date : 2025-12-31

        Dosage Form (Strength) : POWDER (1kg/kg)

        Marketing Category : BULK INGREDIENT

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        Listed Suppliers

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        01

        Interquim SA

        Spain
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        Pharmtech & Ingredients
        Not Confirmed
        • fda
        • EDQM
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        Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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        Tadalafil

        About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...

        Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs that meet stringent quality standards. Complying with European environmental and work safety regulations, Interquim’s products are exported to highly regulated pharmaceutical markets. Regulatory bodies and clients have approved its quality system and facilities. With state-of-the-art multi-production plants, drug synthesis, and quality-control labs, Interquim supports clients throughout the entire product lifecycle, from product development to marketing.
        Interquim

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        02

        Polpharma

        Poland
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        Pharmtech & Ingredients
        Not Confirmed
        • fda
        • EDQM
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        Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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        About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...

        Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
        Polpharma CB

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        03

        LGM Pharma

        U.S.A
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        Not Confirmed
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        Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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        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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        04

        Gonane Pharma

        India
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        CPhI India 2024
        Booth #2.A34
        • fda
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        • WHO-GMP

        Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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        About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

        Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
        Gonane Pharma

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        05

        Jai Radhe Sales

        India
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        CPhI India 2024
        Attending
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        Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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        About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

        Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
        Jai Radhe Sales

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        06

        Shandong Chenghui Shuangda Pharmace...

        China
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        Pharmtech & Ingredients
        Not Confirmed
        • fda
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        Virtual BoothShuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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        About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

        Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
        Shandong Chenghui Shuangda Pharmaceutical

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        07

        Ami Lifesciences Private Limited

        India
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        CPhI India 2024
        Booth #1.C02
        • fda
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        Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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        About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

        Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
        AMI Lifesciences

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        08

        Century Pharmaceuticals

        India
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        CPhI India 2024
        Booth #2.F34
        • fda
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        Virtual BoothCentury has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.

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        About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...

        Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.
        Century Company Banner

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        09

        HRV Global Life Sciences

        India
        arrow
        CPhI India 2024
        Booth #2.D38
        • fda
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        • WHO-GMP

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

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        Tadalafil

        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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        10

        Hubei Gedian Humanwell Pharmaceutic...

        China
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        CPhI India 2024
        Attending
        • fda
        • EDQM
        • WHO-GMP

        Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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        About the Company : Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regula...

        Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regulation drugs and steroidal APIs. It operates as a wholly-owned subsidiary of Humanwell Healthcare Group (Stock Code: 600079), one of the leading pharmaceutical conglomerates in China. The company operates two APIs manufacturing sites, one formulation factory, and one excipients factory, showcasing its commitment to integrating the reproductive health industry chain from raw materials and active pharmaceutical ingredients (APIs) to finished dosage forms.
        Hubei Gedian Humanwell Pharmaceutical

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        API Reference Price

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        [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696271400,"product":"PHARMACEUTICAL RAW MATERIAL-BULK DRUG: TADALAFIL USP 43(SUPP.TAX INV NO.147 DT.26-SEP-23)","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"GEMINI EXPORTS","supplierCountry":"INDIA","foreign_port":"NAVEGANTES","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"155","totalValueFC":"30578.2","currency":"USD","unitRateINR":12725,"date":"03-Oct-2023","totalValueINR":"2545000","totalValueInUsd":"30578.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"4353337","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"A-201\/202, NAVBHARAT EST.,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696357800,"product":"TADALAFIL","address":"MSN HOUSE, PLOT NO.C-24,","city":"HYDERABAD. AP.","supplier":"MSN ORGANICS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"TO THE ORDER OF","customerCountry":"SWITZERLAND","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"396","totalValueFC":"7653.6","currency":"USD","unitRateINR":31850,"date":"04-Oct-2023","totalValueINR":"637000","totalValueInUsd":"7653.6","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"4384825","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO.C-24,, HYDERABAD. AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696357800,"product":"TADALAFIL PH.EUR","address":"425\/3 RT D NO 7-1-621\/328,","city":"HYDERABAD.AP","supplier":"RAKSHIT PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"6.50","actualQuantity":"6.5","unit":"KGS","unitRateFc":"480","totalValueFC":"3063.8","currency":"USD","unitRateINR":39230.769230769234,"date":"04-Oct-2023","totalValueINR":"255000","totalValueInUsd":"3063.8","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"4372289","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696357800,"product":"TADALAFIL PH.EUR","address":"425\/3 RT D NO 7-1-621\/328,","city":"HYDERABAD.AP","supplier":"RAKSHIT PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"480","totalValueFC":"7941.9","currency":"USD","unitRateINR":38882.352941176468,"date":"04-Oct-2023","totalValueINR":"661000","totalValueInUsd":"7941.9","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"4372290","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696357800,"product":"TADALAFIL USP","address":"GHANSHYAM INDL. ESTATE, 11\/II-B,","city":"MUMBAI, MAHARASHTRA.","supplier":"TECHNO EXPORT","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"TO THE ORDER OF","customerCountry":"SINGAPORE","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"219","totalValueFC":"4277.3","currency":"USD","unitRateINR":17800,"date":"04-Oct-2023","totalValueINR":"356000","totalValueInUsd":"4277.3","indian_port":"JNPT","hs_no":"29359090","bill_no":"4394194","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"GHANSHYAM INDL. ESTATE, 11\/II-B,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696530600,"product":"TADALAFIL USP","address":"425\/3 RT D NO 7-1-621\/328,","city":"HYDERABAD.AP","supplier":"RAKSHIT PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"N\/A","customerCountry":"ARGENTINA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"350","totalValueFC":"10139.6","currency":"USD","unitRateINR":28130.333333333332,"date":"06-Oct-2023","totalValueINR":"843910","totalValueInUsd":"10139.6","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"4450548","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696789800,"product":"TADALAFIL USP (MFG TAX INVOICE NO.CSL-189 DT:30.09.2023)","address":"PLOT NO.136\/A, ROAD NO.12,","city":"HYDERABAD.AP.","supplier":"LILLY PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"SUANFARMA","customerCountry":"UNITED STATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"650","totalValueFC":"15679.6","currency":"USD","unitRateINR":52200,"date":"09-Oct-2023","totalValueINR":"1305000","totalValueInUsd":"15679.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4496477","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.136\/A, ROAD NO.12,, HYDERABAD.AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API) EXPORT INVOICE NUMBER : F32418002645 DT. 29.09.2023 TADALAFIL PH.EUR.","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER","customerCountry":"BRAZIL","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"1150","totalValueFC":"28091.1","currency":"USD","unitRateINR":93520,"date":"10-Oct-2023","totalValueINR":"2338000","totalValueInUsd":"28091.1","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4539596","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API) 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AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"TADALAFIL USP,(PACKING:06 DRUMS X 25 KG) BATCH:TD2311004,MFG:OCT 2023,EX P:SEP 2027(RE-IMPORT GOODS)","address":"154, SUKHDEV NAGAR","city":"PANIPAT\/HARYANA","supplier":"SHANGHAI AILINRUI BIOTECHNOLOGY CO., LTD.","supplierCountry":"INDIA","foreign_port":"GUANGZHOU","customer":"SILVERLINE CHEMICAL","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"173.5","totalValueFC":"26568.6","currency":"USD","unitRateINR":"14843.2","date":"28-Sep-2024","totalValueINR":"2226484.29","totalValueInUsd":"26568.6","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"5861336","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUANGZHOU","supplierAddress":"BUILDING C, NO. 888, HUANHU WEST 2ND ROAD.LINGANG NEW AREA CHINA (SHANGHAI) PILOT FREE TRADE ZONE CHINA","customerAddress":"154, SUKHDEV NAGAR"}]
        03-Oct-2023
        30-Oct-2024
        KGS
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        Average Price (USD/KGS)

        Number of Transactions

        Total Quantity (KGS)

        Total Value (USD)

        Quantity (KGS) & Unit rate (USD/KGS) over time

        API Imports and Exports

        Importing Country Total Quantity
        (KGS)        		 Average Price
        (USD/KGS)        		 Number of Transactions

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        INTERMEDIATES SUPPLIERS

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        01

        Hangzhou Longshine Bio-Tech Co.,LTD

        China
        CPhI India 2024
        Not Confirmed
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        Hangzhou Longshine Bio-Tech Co.,LTD

        China
        CPhI India 2024
        Not Confirmed
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        • EDQM
        • WHO-GMP
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        D(+)-Tryptophan

        CAS Number : 153-94-6

        End Use API : Tadalafil

        About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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        02

        Indian Tex Dyes Industries

        India
        CPhI India 2024
        Not Confirmed
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        Indian Tex Dyes Industries

        India
        CPhI India 2024
        Not Confirmed
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        • fda
        • EDQM
        • WHO-GMP
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        1,2,3,4-Tetrhydro-2-chloroacetyl-1-(3,4-methylene ...

        CAS Number : 171489-59-1

        End Use API : Tadalafil

        About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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        03

        Jinan Chenghui Shuangda Chemical

        China
        CPhI India 2024
        Not Confirmed
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        Jinan Chenghui Shuangda Chemical

        China
        CPhI India 2024
        Not Confirmed
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        • fda
        • EDQM
        • WHO-GMP
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        (1R,3R)-9h-pyrido[3,4-b]indole-3-carboxylicacid,1,...

        CAS Number : 171752-68-4

        End Use API : Tadalafil

        About The Company : Jinan Chenghui Shuangda Chemical Co., Ltd is subordinate to Chengchuang Pharmaceutical Group, which is formally established in March, 2002. It is a high-tech en...

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        04

        Scinvapharma

        India
        CPhI India 2024
        Not Confirmed
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        Scinvapharma

        India
        CPhI India 2024
        Not Confirmed
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        • fda
        • EDQM
        • WHO-GMP
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        (1R,3R)-methyl 1-(benzo[d][1,3] dioxol -5-yl)-2-(2...

        CAS Number : 171489-59-1

        End Use API : Tadalafil

        About The Company : Scinva is a startup dedicated to offering high-quality products and services, providing a comprehensive range of services from custom synthesis to the trade of ...

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        05

        Srini Pharmaceuticals

        India
        CPhI India 2024
        Not Confirmed
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        Srini Pharmaceuticals

        India
        CPhI India 2024
        Not Confirmed
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        • fda
        • EDQM
        • WHO-GMP
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        Tadalafil

        CAS Number : 171489-59-1

        End Use API : Tadalafil

        About The Company : Srini Pharmaceuticals Pvt. Ltd., was established in 1995. USFDA, TGA and KFDA approved fully integrated global pharmaceutical company, located just about 60 KM'...

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        06

        V & V Pharma Industries

        India
        CPhI India 2024
        Not Confirmed
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        V & V Pharma Industries

        India
        CPhI India 2024
        Not Confirmed
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        • fda
        • EDQM
        • WHO-GMP
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        3,4-Dihydroxybenzaldehyde

        CAS Number : 139-85-5

        End Use API : Tadalafil

        About The Company : V & V Pharma Industries is a Manufacturer & Exporter of Active Pharmaceutical Ingredients (API's), Pharmaceutical Intermediates & Specialty Chemicals. V & V Pha...

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        Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

        DRUG PRODUCT COMPOSITIONS

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        DOSAGE - TABLET;ORAL - 10MG

        USFDA APPLICATION NUMBER - 21368

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        DOSAGE - TABLET;ORAL - 2.5MG

        USFDA APPLICATION NUMBER - 21368

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        DOSAGE - TABLET;ORAL - 20MG

        USFDA APPLICATION NUMBER - 21368

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        DOSAGE - TABLET;ORAL - 5MG

        USFDA APPLICATION NUMBER - 21368

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        DOSAGE - TABLET;ORAL - 20MG

        USFDA APPLICATION NUMBER - 22332

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        Coating Systems & Additives

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