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    Chemistry

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    Also known as: 162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869
    Molecular Formula
    C17H14Cl2F2N2O3
    Molecular Weight
    403.2  g/mol
    InChI Key
    MNDBXUUTURYVHR-UHFFFAOYSA-N
    FDA UNII
    0P6C6ZOP5U
    Roflumilast
    Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.
    Roflumilast is a Phosphodiesterase 4 Inhibitor. The mechanism of action of roflumilast is as a Phosphodiesterase 4 Inhibitor.
    1 2D Structure

    Roflumilast

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
    2.1.2 InChI
    InChI=1S/C17H14Cl2F2N2O3/c18-11-6-22-7-12(19)15(11)23-16(24)10-3-4-13(26-17(20)21)14(5-10)25-8-9-1-2-9/h3-7,9,17H,1-2,8H2,(H,22,23,24)
    2.1.3 InChI Key
    MNDBXUUTURYVHR-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    0P6C6ZOP5U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

    2. Daliresp

    2.3.2 Depositor-Supplied Synonyms

    1. 162401-32-3

    2. Daxas

    3. 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

    4. Daliresp

    5. By217

    6. Byk20869

    7. By-217

    8. B9302-107

    9. By 217

    10. 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide

    11. Roflumilast (daxas)

    12. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

    13. Byk-20869

    14. 0p6c6zop5u

    15. Chembl193240

    16. Chebi:47657

    17. 3-cyclopropylmethoxy-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

    18. Byk 20869

    19. Mfcd00938270

    20. B 9302-107

    21. Rof

    22. Libertek

    23. Roflumilast [usan]

    24. B-9302-107

    25. Roflumilast [usan:inn]

    26. Unii-0p6c6zop5u

    27. Roflumilastum

    28. Roflumilast (jan/usan/inn)

    29. Apta-2217

    30. 1xmu

    31. 1xoq

    32. Daliresp (tn)

    33. Roflumilast- Bio-x

    34. 3g4l

    35. Roflumilast [mi]

    36. Roflumilast [inn]

    37. Roflumilast [jan]

    38. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

    39. Roflumilast [vandf]

    40. Roflumilast [mart.]

    41. Schembl19158

    42. Roflumilast [who-dd]

    43. Mls006010074

    44. Roflumilast [ema Epar]

    45. Gtpl6962

    46. Dtxsid8044123

    47. Apta 2217

    48. Bdbm14774

    49. Roflumilast, >=98% (hplc)

    50. Amy4219

    51. Ex-a059

    52. Roflumilast [orange Book]

    53. Hms3655p21

    54. Hms3748c19

    55. Hms3884f09

    56. Zinc592419

    57. Act02619

    58. Bcp03736

    59. S2131

    60. Arq-151/zoryve (roflumilast Cream)

    61. Akos005146309

    62. Am84550

    63. Ccg-268678

    64. Cs-0963

    65. Db01656

    66. Pb29130

    67. Ncgc00346566-01

    68. Ncgc00346566-09

    69. Ac-23383

    70. As-14120

    71. Br164364

    72. Hy-15455

    73. Smr002530074

    74. Sy008710

    75. Bcp0726000146

    76. Ft-0660846

    77. R0193

    78. Sw220196-1

    79. A24672

    80. D05744

    81. Ab01565852_02

    82. 401r323

    83. Q693482

    84. J-510858

    85. Brd-k03194791-001-02-2

    86. 3- Cyclo-propylmethoxy-4-difluoromethoxy-n- [3, 5-di-chloropyrid-4-yl]- Benzamid

    87. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

    88. N-(3,5-dichloropyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 403.2 g/mol
    Molecular Formula C17H14Cl2F2N2O3
    XLogP34.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count7
    Exact Mass402.0349540 g/mol
    Monoisotopic Mass402.0349540 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity475
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameDaliresp
    PubMed HealthRoflumilast (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelThe active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
    Active IngredientRoflumilast
    Dosage FormTablet
    RouteOral
    Strength500mcg
    Market StatusPrescription
    CompanyForest Res Inst

    2 of 2  
    Drug NameDaliresp
    PubMed HealthRoflumilast (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelThe active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
    Active IngredientRoflumilast
    Dosage FormTablet
    RouteOral
    Strength500mcg
    Market StatusPrescription
    CompanyForest Res Inst

    4.2 Drug Indication

    Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

    FDA Label

    Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

    Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

    Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

    Chronic obstructive pulmonary disease

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Roflumilast (and its active metabolite, roflumilast N-oxide) increases cyclic adenosine-3, 5-monophosphate (cAMP) in lung cells by inhibiting PDE4. Increased cAMP activates PKA, which inactivates transcription factors involved in inflammation. Romflumilast also decreases the amount of sputum neutrophils and eosinophils in COPD patients.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    ROFLUMILAST
    5.2.2 FDA UNII
    0P6C6ZOP5U
    5.2.3 Pharmacological Classes
    Phosphodiesterase 4 Inhibitors [MoA]; Phosphodiesterase 4 Inhibitor [EPC]
    5.3 ATC Code

    R03DX07

    R03DX08

    R03DX07

    R03DX07

    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

    R - Respiratory system

    R03 - Drugs for obstructive airway diseases

    R03D - Other systemic drugs for obstructive airway diseases

    R03DX - Other systemic drugs for obstructive airway diseases

    R03DX07 - Roflumilast

    5.4 Absorption, Distribution and Excretion

    Absorption

    After a 500mcg dose, the bioavailability of roflumilast is about 80%. In the fasted state, maximum plasma concentrations are reached in 0.5 to 2 hours. While in the fed state, Cmax is reduced by 40%, Tmax is increased by one hour, and total absorption is unchanged.

    Route of Elimination

    Roflumilast is excreted 70% in the urine as roflumilast N-oxide.

    Volume of Distribution

    Roflumilast has a Vd of 2.9L/kg with a dose of 500mcg. Permeability of roflumilast across the blood-brain barrier appears to be poor in rat studies.

    Clearance

    ~9.6 L/hour.

    5.5 Metabolism/Metabolites

    Roflumilast is metabolized to roflumilast N-oxide, the active metabolite of roflumilast in humans, by CYP3A4 and CYP1A2.

    5.6 Biological Half-Life

    Plasma half-life of roflumilast is 17 hours and its metabolite is 30 hours (oral dose).

    5.7 Mechanism of Action

    Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

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    Roflumilast IH

    Date of Issue : 2019-10-11

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0157

    Address of the Firm : Plot No. 1A/2, MIDC, Taloja, Panvel, Dist. Raigad, Maharashtra State

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    KDMF

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    01

    Interquim SA

    Spain
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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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    Roflumilast

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2016-12-29

    Registration Number : Su259-4-ND

    Manufacturer Name : Interquim, SA

    Manufacturer Address : Joan Buscalla 10, E-08173 Sant Cugat del Valles, Barcelona, ​​Spain

    Interquim

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    02

    MSN Laboratories

    India
    Antibody Engineering
    Not Confirmed
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    MSN Laboratories

    India
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    Roflumilast

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2017-04-03

    Registration Number : Su258-2-ND

    Manufacturer Name : MSN Laboratories Private Lim...

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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    03

    Siegfried AG

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Siegfried AG

    Switzerland
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    Roflumilast

    Registrant Name : AstraZeneca Korea Ltd.

    Registration Date : 2014-09-17

    Registration Number : Su5550-4-ND

    Manufacturer Name : Siegfried Evionnaz SA_x000D_...

    Manufacturer Address : Route du Simplon 1, 36, 1902 Evionnaz, Switzerland_x000D_ @[Pulverization Process] Vi...

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    04

    Takeda Pharmaceutical

    Japan
    Antibody Engineering
    Not Confirmed
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    Takeda Pharmaceutical

    Japan
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    Roflumilast

    Registrant Name : AstraZeneca Korea Ltd.

    Registration Date : 2011-04-29

    Registration Number : Su5550-1-ND

    Manufacturer Name : Takeda GmbH, Production site...

    Manufacturer Address : Robert-Bosch-Strass 8 78224 Singen Germany

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    NDC API

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    01

    Interquim, S.A.

    Spain
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    ROFLUMILAST

    NDC Package Code : 64552-4096

    Start Marketing Date : 2011-02-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    Interquim

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    02

    Interquim, S.A.

    Spain
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    ROFLUMILAST

    NDC Package Code : 64552-4067

    Start Marketing Date : 2011-02-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    Interquim

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    03

    Interquim, S.A.

    Spain
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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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    ROFLUMILAST

    NDC Package Code : 64552-4053

    Start Marketing Date : 2011-02-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    Interquim

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    04

    Aurobindo Pharma Limited

    India
    Antibody Engineering
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    ROFLUMILAST

    NDC Package Code : 59651-222

    Start Marketing Date : 2023-12-07

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Hetero Drugs Limited

    India
    Antibody Engineering
    Not Confirmed
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    Hetero Drugs Limited

    India
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    ROFLUMILAST

    NDC Package Code : 65977-0111

    Start Marketing Date : 2011-02-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    MSN Laboratories Private Limited

    India
    Antibody Engineering
    Not Confirmed
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    MSN Laboratories Private Limited

    India
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    ROFLUMILAST

    NDC Package Code : 14501-0078

    Start Marketing Date : 2012-03-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    SciAnda(Changshu) Pharmaceuticals, ...

    Taiwan
    Antibody Engineering
    Not Confirmed
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    SciAnda(Changshu) Pharmaceuticals, ...

    Taiwan
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    ROFLUMILAST

    NDC Package Code : 54245-7016

    Start Marketing Date : 2013-12-02

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    Sintenovo SA de CV

    Mexico
    Antibody Engineering
    Not Confirmed
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    Sintenovo SA de CV

    Mexico
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    ROFLUMILAST

    NDC Package Code : 61730-0010

    Start Marketing Date : 2023-12-06

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    MYLAN LABORATORIES LIMITED

    U.S.A
    Antibody Engineering
    Not Confirmed
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    MYLAN LABORATORIES LIMITED

    U.S.A
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    ROFLUMILAST

    NDC Package Code : 65015-850

    Start Marketing Date : 2015-02-20

    End Marketing Date : 2026-12-01

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

    Marketing Category : BULK INGREDIENT

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    10

    Viyash Life Sciences Private Limite...

    India
    Antibody Engineering
    Not Confirmed
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    Viyash Life Sciences Private Limite...

    India
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    ROFLUMILAST

    NDC Package Code : 82245-0118

    Start Marketing Date : 2018-01-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    Interquim SA

    Spain
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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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    Roflumilast

    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

    M2i Group

    France
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    Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.

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    Roflumilast

    About the Company : Integrated solutions for all your projects.
    M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development...

    Integrated solutions for all your projects. M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development to commercial supply of high-value niche fine chemicals for the pharmaceutical and biocontrol industry. Our offerings include: - Proprietary molecule portfolio: API, synthesis intermediates, key building blocks & pheromones - Custom development & manufacturing: Process development, industrialization & production - Contract Research: Outsourced research services - Consulting/accompaniment: R&D, innovation, key sourcing & industrial strategy
    m2i group

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    03

    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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    Roflumilast

    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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    HRV Global Life Sciences

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

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    Roflumilast

    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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    05

    CHEMO

    Spain
    Antibody Engineering
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    CHEMO

    Spain
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    About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

    More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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    06

    Chongqing Huapont Pharmaceutical

    China
    Antibody Engineering
    Not Confirmed
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    Chongqing Huapont Pharmaceutical

    China
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    Roflumilast

    About the Company : Chongqing Huapont Pharmaceutical Co., Ltd. was established in 1994 and is now located in Liangjiang New District, Chongqing. It is a national high-tech enterprise, a national innov...

    Chongqing Huapont Pharmaceutical Co., Ltd. was established in 1994 and is now located in Liangjiang New District, Chongqing. It is a national high-tech enterprise, a national innovative enterprise, and a national demonstration enterprise for a new model of intelligent manufacturing. It has a national enterprise technology center and multiple municipal R&D platforms, two formulation factories, and two API factories. In addition, the company is also widely involved in the fields of respiratory, cardiovascular and cerebrovascular, blood, tumor, and systemic hormones, and has accumulated a large number of blockbuster drugs.
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    07

    DEAFARMA

    Italy
    Antibody Engineering
    Not Confirmed
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    DEAFARMA

    Italy
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    About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

    In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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    08

    Glenmark Pharmaceuticals

    India
    Antibody Engineering
    Not Confirmed
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    Glenmark Pharmaceuticals

    India
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    About the Company : Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in mark...

    Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.
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    09

    Hetero Drugs

    India
    Antibody Engineering
    Not Confirmed
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    Hetero Drugs

    India
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    Roflumilast

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    10

    Hunan Huateng Pharmaceutical Co ltd

    China
    Antibody Engineering
    Not Confirmed
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    Hunan Huateng Pharmaceutical Co ltd

    China
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    Not Confirmed
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    About the Company : Hunan Huateng Pharmaceutical Co., Ltd. is a research-based manufacturer and supplier of combinatorial building blocks, organics and fine chemicals, with 5000m2 laboratory and over ...

    Hunan Huateng Pharmaceutical Co., Ltd. is a research-based manufacturer and supplier of combinatorial building blocks, organics and fine chemicals, with 5000m2 laboratory and over 100 experienced chemists. Huateng is dedicated to bring high quality and cost effective chemical products and services to our clients. Our versatile chemical synthesis expertise and manufacturing capability prepare us to produce a variety of known, novel or even hard-to-find chemicals from kg to ton scale.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"ROFLUMILAST","year":"2021","qtr":"Q1","strtotime":1610044200,"product":"ROFLUMILAST IH","address":"HETERO HOUSE, H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"PERRIGO COMPANY PLC","customerCountry":"ISRAEL","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"180321.4","totalValueFC":"1825.7","currency":"USD","unitRateINR":13352800,"date":"08-Jan-2021","totalValueINR":"133528","totalValueInUsd":"1825.7","indian_port":"HYDERABAD AIR","hs_no":"29333911","bill_no":"7764282","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE, H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"ROFLUMILAST","year":"2021","qtr":"Q2","strtotime":1618943400,"product":"ROFLUMILAST (GROUP:B SR NO:8119) (TAX IN","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"MONTREAL","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"CANADA","quantity":"0.11","actualQuantity":"0.105","unit":"KGS","unitRateFc":"200000","totalValueFC":"20873.3","currency":"USD","unitRateINR":14800000,"date":"21-Apr-2021","totalValueINR":"1554000","totalValueInUsd":"20873.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"1257100","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","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":"","year":"2021","qtr":"Q2","strtotime":1622485800,"product":"ROFLUMILAST (TAX INVOICE NO:1900215171 DT:24-05-2021) (GROUP:A","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"PERRIGO COMPANY PLC","customerCountry":"ISRAEL","quantity":"0.01","actualQuantity":"0.007","unit":"KGS","unitRateFc":"251040.9","totalValueFC":"1721.6","currency":"USD","unitRateINR":18087500,"date":"01-Jun-2021","totalValueINR":"126612.5","totalValueInUsd":"1721.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"2146621","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","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":"","year":"2021","qtr":"Q4","strtotime":1637519400,"product":"ROFLUMILAST (TAX INVOICE NO:1900215903","address":"8-3-167\/D\/16, KALYAN NAGAR - I,VENGAL RAO NAGAR","city":"HYDERABAD, A.P.","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"CANADA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"200000","totalValueFC":"58908.6","currency":"USD","unitRateINR":14623333.333333334,"date":"22-Nov-2021","totalValueINR":"4387000","totalValueInUsd":"58908.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"6169958","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","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":"","year":"2022","qtr":"Q1","strtotime":1648233000,"product":"339977 - ROFLUMILAST - NN4297","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU","city":"BANGALORE,KARNATAKA","supplier":"APOTEX INC","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"ADLI LOGISTICS","customerCountry":"CANADA","quantity":"0.16","actualQuantity":"0.159","unit":"KGS","unitRateFc":"79078.1","totalValueFC":"12411.5","currency":"USD","unitRateINR":5949685.5345911952,"date":"26-Mar-2022","totalValueINR":"946000","totalValueInUsd":"12411.5","indian_port":"BANGALORE ICD","hs_no":"29331999","bill_no":"9222536","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE ICD","supplierAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656873000,"product":"ROFLUMILAST","address":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"TO THE ORDER OF","customerCountry":"CHINA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"225000","totalValueFC":"327101.8","currency":"USD","unitRateINR":17340000,"date":"04-Jul-2022","totalValueINR":"26010000","totalValueInUsd":"327101.8","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"2594140","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691087400,"product":"CS-O-11739 \/ ROFLUMILAST","address":"NA","city":"MUMBAI","supplier":"CLEARSYNTH LABS LIMITED","supplierCountry":"INDIA","foreign_port":"HO CHI MINH CITY","customer":"NAVIS VIETNAM CO LIMITED","customerCountry":"VIETNAM","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"240","totalValueFC":"236.6","currency":"USD","unitRateINR":19600.308000000001,"date":"04-Aug-2023","totalValueINR":"19600.308","totalValueInUsd":"236.6","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"NA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696617000,"product":"ROFLUMILAST","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"TO THE ORDER OF,....;;","customerCountry":"CANADA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"100000","totalValueFC":"98679.2","currency":"USD","unitRateINR":8213000,"date":"07-Oct-2023","totalValueINR":"8213000","totalValueInUsd":"98679.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4469065","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","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":1697567400,"product":"ROFLUMILAST RC B(NET WT: 500 GM X 1 VIAL) (PRODUCT VALVE= 1.85 USD X 500 MG = 925 USD)","address":"PLOT NO. 2, SY NO.110,","city":"SECUNDERABAD, TELANGANA.","supplier":"VENKATASAI LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"HAIFA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"ISRAEL","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"1890","totalValueFC":"913.1","currency":"USD","unitRateINR":152000,"date":"18-Oct-2023","totalValueINR":"76000","totalValueInUsd":"913.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4732045","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. 2, SY NO.110,, SECUNDERABAD, TELANGANA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715711400,"product":"ROFLUMILAST","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZYDUS LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"FARMATRADE SRL","customerCountry":"ARGENTINA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"85","totalValueFC":"802.7","currency":"USD","unitRateINR":6690.6000000000004,"date":"15-May-2024","totalValueINR":"66906","totalValueInUsd":"802.7","indian_port":"Ahmedabad Air","hs_no":"29333929","bill_no":"9878873","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719167400,"product":"ROFLUMILAST USP (AS PER INV)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"MSN PHARMACEUTICALS INC","customerCountry":"UNITED STATES","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"153915","totalValueFC":"121712.2","currency":"USD","unitRateINR":12700582.987500001,"date":"24-Jun-2024","totalValueINR":"10160466.39","totalValueInUsd":"121712.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1896941","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"ROFLUMILAST","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"PHARMAPIA CO. LTD","customerCountry":"REPUBLIC OF KOREA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"180000","totalValueFC":"53343.7","currency":"USD","unitRateINR":14863526.666666668,"date":"11-Jul-2024","totalValueINR":"4459058","totalValueInUsd":"53343.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2344233","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHANGHAI - PU DONG","customer":"ZHEJIANG HUAHAI PHARMA CO., LTD","customerCountry":"CHINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"215000","totalValueFC":"212588.9","currency":"USD","unitRateINR":17770534.289999999,"date":"12-Jul-2024","totalValueINR":"17770534.29","totalValueInUsd":"212588.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2379334","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721241000,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"MSN PHARMACEUTICALS INC.","customerCountry":"UNITED STATES","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"153915","totalValueFC":"30324.7","currency":"USD","unitRateINR":12674360.5,"date":"18-Jul-2024","totalValueINR":"2534872.1","totalValueInUsd":"30324.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2504680","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""}]
    08-Jan-2021
    18-Jul-2024
    KGS
    overview
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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

    M2i Group

    France
    Antibody Engineering
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    Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.

    Cyclopropyl Methyl Bromide

    CAS Number : 7051-34-5

    End Use API : Roflumilast

    About The Company : Integrated solutions for all your projects.
    M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...

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    02

    Minakem

    France
    DCAT Week
    Attending
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    Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

    Cyclopropyl Methyl Chloride

    CAS Number : 5911-08-0

    End Use API : Roflumilast

    About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...

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    03

    Minakem

    France
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    Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

    Cyclopropyl Methyl Bromide

    CAS Number : 7051-34-5

    End Use API : Roflumilast

    About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...

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    04

    Faran Shimi Pharmaceutical

    Iran
    Antibody Engineering
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Cyclopropylmethyl Bromide

    CAS Number : 7051-34-5

    End Use API : Roflumilast

    About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

    Faran Shimi Pharmaceutical

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    05

    LinkChem

    China
    Antibody Engineering
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    LinkChem

    China
    Antibody Engineering
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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.

    methyl 4-(difluoromethoxy)-3-hydroxybenzoate

    CAS Number : 1159429-52-3

    End Use API : Roflumilast

    About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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    06

    V & V Pharma Industries

    India
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    V & V Pharma Industries

    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.

    3,4-Dihydroxybenzaldehyde

    CAS Number : 139-85-5

    End Use API : Roflumilast

    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]

    FDA Orange Book

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    01

    BRECKENRIDGE

    U.S.A
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    RLD : No

    TE Code :

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2018-10-03

    Application Number : 208236

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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    BRECKENRIDGE

    U.S.A
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    RLD : No

    TE Code :

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-10-19

    Application Number : 208236

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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    03

    STRIDES PHARMA

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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    Flag India
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2020-03-30

    Application Number : 208247

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Strides Pharma Science

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    04

    STRIDES PHARMA

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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    Flag India
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-06-20

    Application Number : 208247

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Strides Pharma Science

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    05

    ALKEM LABS LTD

    India
    Antibody Engineering
    Not Confirmed
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    ALKEM LABS LTD

    India
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-04-18

    Application Number : 212490

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    ALKEM LABS LTD

    India
    Antibody Engineering
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    ALKEM LABS LTD

    India
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    Antibody Engineering
    Not Confirmed
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2023-04-18

    Application Number : 212490

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    HETERO LABS LTD III

    India
    Antibody Engineering
    Not Confirmed
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    HETERO LABS LTD III

    India
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2018-11-23

    Application Number : 208213

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    MICRO LABS

    India
    Antibody Engineering
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    MICRO LABS

    India
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2019-03-22

    Application Number : 208180

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    MICRO LABS

    India
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    MICRO LABS

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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 250MCG

    Approval Date : 2023-04-18

    Application Number : 208180

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    ZYDUS PHARMS

    U.S.A
    Antibody Engineering
    Not Confirmed
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    ZYDUS PHARMS

    U.S.A
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    Antibody Engineering
    Not Confirmed
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    RLD : No

    TE Code : AB

    ROFLUMILAST

    Brand Name : ROFLUMILAST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MCG

    Approval Date : 2022-02-10

    Application Number : 208303

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    01

    2care4 Generics ApS

    Denmark
    Antibody Engineering
    Not Confirmed
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    2care4 Generics ApS

    Denmark
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    Regulatory Info :

    Registration Country : Norway

    Roflumilast

    Brand Name : Quadruple

    Dosage Form : Tablet, film-coated

    Dosage Strength : 500 micrograms

    Packaging : Blisterpakning 30item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    2care4 Generics ApS

    Denmark
    Antibody Engineering
    Not Confirmed
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    2care4 Generics ApS

    Denmark
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    Regulatory Info :

    Registration Country : Norway

    Roflumilast

    Brand Name : Quadruple

    Dosage Form : Tablet, film-coated

    Dosage Strength : 500 micrograms

    Packaging : Blisterpakning 90item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    AstraZeneca AB (2)

    United Kingdom
    Antibody Engineering
    Not Confirmed
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    AstraZeneca AB (2)

    United Kingdom
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Roflumilast

    Brand Name : Daxas

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 500 mcg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    04

    AstraZeneca AB (2)

    United Kingdom
    Antibody Engineering
    Not Confirmed
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    AstraZeneca AB (2)

    United Kingdom
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Roflumilast

    Brand Name : Daxas

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 500 mcg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    05

    AstraZeneca AG

    United Kingdom
    Antibody Engineering
    Not Confirmed
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    AstraZeneca AG

    United Kingdom
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Roflumilastum

    Brand Name : Daxas

    Dosage Form : Filmtabl

    Dosage Strength : 500mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    06

    Orifarm AS

    Denmark
    Antibody Engineering
    Not Confirmed
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    Orifarm AS

    Denmark
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Roflumilast

    Brand Name : Daxas

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 500 mcg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    Takeda GmbH

    Japan
    Antibody Engineering
    Not Confirmed
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    Takeda GmbH

    Japan
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    roflumilast

    Brand Name : Daxas

    Dosage Form : FILM COATED PILL

    Dosage Strength : 500 MICROGRAMS

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    08

    Takeda GmbH

    Japan
    Antibody Engineering
    Not Confirmed
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    Takeda GmbH

    Japan
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    roflumilast

    Brand Name : Libertek

    Dosage Form : FILM COATED PILL

    Dosage Strength : 500 MICROGRAMS

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    09

    TAKEDA GMBH

    Japan
    Antibody Engineering
    Not Confirmed
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    TAKEDA GMBH

    Japan
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    Antibody Engineering
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Roflumilast

    Brand Name : Daxas

    Dosage Form : Roflumilast 500Mcg 30 Joined' Oral Use

    Dosage Strength : 30 cpr riv 500 mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Country
    Antibody Engineering
    Not Confirmed
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    Country
    arrow
    Antibody Engineering
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    Regulatory Info :

    Registration Country : Spain

    Roflumilast

    Brand Name : 30 Libertek 500Mcg Film-Coated Tablets

    Dosage Form : Film Coated Tablet

    Dosage Strength : 500 Mcg/Film Coated Tablet

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Spain

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 250MCG

    USFDA APPLICATION NUMBER - 22522

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    DOSAGE - TABLET;ORAL - 500MCG

    USFDA APPLICATION NUMBER - 22522

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