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    Also known as: 441798-33-0, Opsumit, Act-064992, Act 064992, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide, Act064992
    Molecular Formula
    C19H20Br2N6O4S
    Molecular Weight
    588.3  g/mol
    InChI Key
    JGCMEBMXRHSZKX-UHFFFAOYSA-N
    FDA UNII
    Z9K9Y9WMVL
    Macitentan
    Macitentan is an orally available dual endothelin receptor (ETR) antagonist with potential antihypertensive and antineoplastic activity. Upon administration, macitentan and its metabolites block the binding of endothelin isoform 1 (ET-1) to type-A and type-B ETR on both the tumor cells and the endothelial cells in the tumor vasculature. This prevents ET-1 mediated signaling transduction which may decrease tumor cell proliferation, progression, and angiogenesis in tumor tissue. ET-1, a potent vasoconstrictor that plays an important role in inflammation and tissue repair, is, together with its receptors, overexpressed varyingly in many tumor cell types.
    Macitentan is an Endothelin Receptor Antagonist. The mechanism of action of macitentan is as an Endothelin Receptor Antagonist.
    1 2D Structure

    Macitentan

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine
    2.1.2 InChI
    InChI=1S/C19H20Br2N6O4S/c1-2-7-26-32(28,29)27-17-16(13-3-5-14(20)6-4-13)18(25-12-24-17)30-8-9-31-19-22-10-15(21)11-23-19/h3-6,10-12,26H,2,7-9H2,1H3,(H,24,25,27)
    2.1.3 InChI Key
    JGCMEBMXRHSZKX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCNS(=O)(=O)NC1=C(C(=NC=N1)OCCOC2=NC=C(C=N2)Br)C3=CC=C(C=C3)Br
    2.2 Other Identifiers
    2.2.1 UNII
    Z9K9Y9WMVL
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Act 064992

    2. Act-064992

    3. Act064992

    4. Actelion-1

    5. N-(5-(4-bromophenyl)-6-(2-(5-bromopyrimidin-2-yloxy)ethoxy)pyrimidin-4-yl)-n'-propylaminosulfonamide

    6. Opsumit

    2.3.2 Depositor-Supplied Synonyms

    1. 441798-33-0

    2. Opsumit

    3. Act-064992

    4. Act 064992

    5. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide

    6. Act064992

    7. Z9k9y9wmvl

    8. 5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-n-(propylsulfamoyl)pyrimidin-4-amine

    9. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-n'-propylsulfamide

    10. Chebi:76607

    11. Actelion-1

    12. Macitentan [inn]

    13. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)-n'-propylsulfamide

    14. N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-n'- Propylsulfamide

    15. Macitentan [usan:inn]

    16. Unii-z9k9y9wmvl

    17. Macitentanum

    18. Sulfamide, N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-n'-propyl-

    19. Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-

    20. Macitentan- Bio-x

    21. Opsumit (tn)

    22. Macitentan [mi]

    23. Macitentan [jan]

    24. Macitentan (jan/usan)

    25. Macitentan [usan]

    26. Macitentan [vandf]

    27. (non-labelled)macitentan-d7

    28. Macitentan [who-dd]

    29. Mls006011174

    30. Gtpl7352

    31. Schembl1445625

    32. Chembl2103873

    33. Macitentan [orange Book]

    34. Dtxsid50196063

    35. Ex-a544

    36. Hms3653n06

    37. Hms3747e09

    38. Cas:441798-33-0;macitentan

    39. Bcp05309

    40. Bdbm50395626

    41. Mfcd17167076

    42. S8051

    43. Zinc43202140

    44. Akos024463406

    45. Am81244

    46. Ccg-270155

    47. Cs-0686

    48. Db08932

    49. Sb14841

    50. Macitentan (actelion-1,act-064992)

    51. Ncgc00346456-01

    52. Ncgc00346456-05

    53. Ac-30102

    54. As-74590

    55. Bm162771

    56. Hy-14184

    57. N-(5-(4-bromophenyl)-6-(2-(5-bromopyrimidin-2-yloxy)ethoxy)pyrimidin-4-yl)-n'-propylaminosulfonamide

    58. Smr004702943

    59. Db-070519

    60. Ft-0696675

    61. Sw219473-1

    62. Act 064992; Act-064992

    63. D10135

    64. Q6724151

    65. {[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]sulfamoyl}(propyl)amine

    66. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxi)ethoxy)pyrimidin-4-yl)-n'-propylsulfuric Diamide

    67. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)-oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide

    68. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-sulfamide

    69. N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-n'-propylsulfuric Diamide

    2.4 Create Date
    2007-04-02
    3 Chemical and Physical Properties
    Molecular Weight 588.3 g/mol
    Molecular Formula C19H20Br2N6O4S
    XLogP33.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count11
    Exact Mass587.96130 g/mol
    Monoisotopic Mass585.96335 g/mol
    Topological Polar Surface Area137 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity642
    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 NameOpsumit
    PubMed HealthMacitentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelOPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecula
    Active IngredientMacitentan
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyActelion Pharms

    2 of 2  
    Drug NameOpsumit
    PubMed HealthMacitentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelOPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecula
    Active IngredientMacitentan
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyActelion Pharms

    4.2 Drug Indication

    Investigated for use/treatment in cardiovascular disorders, hypertension, and pulmonary hypertension.

    Macitentan is indicated for the treatment of WHO group 1 pulmonary arterial hypertension (PAH) both alone and in combination with tadalafil.

    FDA Label

    Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.

    Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

    Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)

    Treatment of idiopathic pulmonary fibrosis, Treatment of pulmonary arterial hypertension, Treatment of systemic sclerosis

    Treatment of functional single ventricle heart disease with total cavo-pulmonary connection

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Macitentan acts primarily by reducing vasoconstriction and cell proliferation due to endothelin overexpression.

    5.2 MeSH Pharmacological Classification

    Endothelin A Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN A RECECPTORS. (See all compounds classified as Endothelin A Receptor Antagonists.)

    Endothelin B Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN B RECEPTORS. (See all compounds classified as Endothelin B Receptor Antagonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    MACITENTAN
    5.3.2 FDA UNII
    Z9K9Y9WMVL
    5.3.3 Pharmacological Classes
    Endothelin Receptor Antagonists [MoA]; Endothelin Receptor Antagonist [EPC]
    5.4 ATC Code

    C02KX04

    C02KX04

    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

    C - Cardiovascular system

    C02 - Antihypertensives

    C02K - Other antihypertensives

    C02KX - Antihypertensives for pulmonary arterial hypertension

    C02KX04 - Macitentan

    5.5 Absorption, Distribution and Excretion

    Absorption

    Macitentan has a median Tmax of 8h although some studies have found up to 30h at higher doses. Although the bioavailability has not been experimentally determined, pharmacokinetic modeling has estimated it at 74%. Food has not been found to have a significant effect on absorption.

    Route of Elimination

    Eliminated 50% through urine and 24% through feces. Of the 50% excreted through the urine, none of the recovered dose was in the form of the parent drug nor the active metabolite.

    Volume of Distribution

    Macitentan has an apparent volume of distribution of 40-50L.

    Clearance

    Clearance data was not found.

    5.6 Metabolism/Metabolites

    Macitentan undergoes oxidative depropylation of the sulfonamide moiety via CYP3A4, 2C8, 2C9, and 2C19 to form the active metabolite M6. The ethylene glycol moiety undergoes oxidative cleavage via CYP2C9 to the alcohol metabolite M4. M4 is oxidized to its corresponding acid, M5, then hydrolyzed to the metabolite termed m/z 324. Oxidative depropylation of a distal carbon atom via CYP2C8, 2C9, and 2C19 forms M7. Hydrolysis of both macitentan and M5 produces M3. Finally M5 may be further metabolized via hydrolysis and hydroxylation to M2 or via glucuronidation to a glucuronide metabolite, M1.

    5.7 Biological Half-Life

    The half-life of elimination of macitentan is 16 hours. The half-life of elimination of the active metabolite is 40-66h

    5.8 Mechanism of Action

    Through complete blockade of tissular endothelin, Actelion-1 is expected to protect tissue from the damaging effect of elevated endothelin, specifically in the cardiovascular system. In pre-clinical studies, Actelion-1 also exhibited effects suggesting that it maintains the integrity of the vascular wall and improves long-term outcome. Accordingly, Actelion-1 may provide therapeutic benefit in a wide range of cardiovascular indications.

    Macitentan is an antagonist which binds to the endothelin A and B receptors (EA and EB) and blocks signaling from endothelin-1 and -2. Pulmonary arterial hypertension has many different mechanisms which contribute to the development of endothelial dysfunction including elevated cytosolic calcium, genetic factors, epigenetic changes, and mitochondrial dysfunction. The focus of macitentan's mechanism relates to the role of overexpressed endothelin from the vascular endothelium. Endothelins are released in both a constitutive fashion from secretory vesicles and in response to stimuli via Weibel-Palade storage granules. Endothelins bind to the EA and EB receptors, with endothelins -1 and -2 having more affinity than endothelin-3. Binding to the Gq coupled EA receptor triggers Ca2+ release from the sarcoplasmic reticulum of smooth muscle cells via the phospholipase C (PLC) pathway. Downstream protein kinase C activation may also contribute to increased Ca2+ sensitivity of the contractile apparatus. EA receptor activation is also known to contribute to pulmonary artery smooth muscle cell proliferation. The binding of endothelins to the EB receptors acts in opposition to EA signaling by activating the same PLC cascade in endothelial cells to activate endothelial nitric oxide synthase. The subsequent release of nitric oxide produces vasodilation through the cyclic guanosine monophosphate cascade. Despite the greater presence of EB receptors on endothelial cells, they are still present on smooth muscle cells and may contribute to cell proliferation through the same mechanisms as EA receptors. Macitentan is thought to provide its therapeutic effect primarily via blocking signaling through EA which produces both decreased vasoconstriction via reduced smooth muscle cell contractility and attenuation of the hyperproliferation of smooth muscle cells found in PAH. Blockade of EB is less likely to contribute to a therapeutic effect as this signaling is responsible for the counter-regulatory vasodilatory signal.

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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-06-01

    Pay. Date : 2017-05-12

    DMF Number : 31749

    Submission : 2017-05-15

    Status : Active

    Type : II

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    Laurus Labs Ltd

    India

    USDMF

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    05

    Laurus Labs Ltd

    India
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-10-12

    Pay. Date : 2017-08-30

    DMF Number : 31957

    Submission : 2017-09-15

    Status : Active

    Type : II

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    AACR Annual meeting
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    06

    Msn Life Sciences Private Ltd

    India
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-12-22

    Pay. Date : 2016-09-29

    DMF Number : 30212

    Submission : 2016-01-30

    Status : Active

    Type : II

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    Raks Pharma Pvt Ltd

    India

    USDMF

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    Not Confirmed

    07

    Raks Pharma Pvt Ltd

    India
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    AACR Annual meeting
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-01-24

    Pay. Date : 2016-12-05

    DMF Number : 31179

    Submission : 2016-12-13

    Status : Active

    Type : II

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    AACR Annual meeting
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    08

    Seasons Biotechnology (taizhou) Co L...

    China
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-06-22

    Pay. Date : 2017-06-05

    DMF Number : 31658

    Submission : 2017-05-31

    Status : Active

    Type : II

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    09

    Matrix Pharmacorp Private Ltd

    U.S.A
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-01-04

    Pay. Date : 2016-09-27

    DMF Number : 30969

    Submission : 2016-09-30

    Status : Active

    Type : II

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    10

    AACR Annual meeting
    Not Confirmed

    10

    Zhejiang Guobang Pharmaceutical Co L...

    China
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39273

    Submission : 2023-12-12

    Status : Active

    Type : II

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    JDMF

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    01

    Ryoto Fine Co., Ltd.

    Japan
    AACR Annual meeting
    Not Confirmed
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    Ryoto Fine Co., Ltd.

    Japan
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    Masitentan

    Registration Number : 308MF10004

    Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture

    Initial Date of Registration : 2026-01-08

    Latest Date of Registration : 2026-01-08

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    02

    Viyash Life Sciences Private Limite...

    India
    AACR Annual meeting
    Not Confirmed
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    Viyash Life Sciences Private Limite...

    India
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    AACR Annual meeting
    Not Confirmed
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    Macitentan

    Registration Number : 308MF10029

    Registrant's Address : Plot No. 290, Srivalli's Corporate, Road No. 6, Kakatiya Hills, Madhapur, Hyderabad-5...

    Initial Date of Registration : 2026-02-06

    Latest Date of Registration : 2026-02-06

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    03

    Zhejiang Ausun Pharmaceutical Co. ,...

    China
    AACR Annual meeting
    Not Confirmed
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    Zhejiang Ausun Pharmaceutical Co. ,...

    China
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    Masitentan

    Registration Number : 307MF10112

    Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...

    Initial Date of Registration : 2025-09-03

    Latest Date of Registration : 2025-09-03

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    04

    Zhejiang Huayi Pharmaceutical Co. ,...

    China
    AACR Annual meeting
    Not Confirmed
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    Zhejiang Huayi Pharmaceutical Co. ,...

    China
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    Masitentan

    Registration Number : 307MF10144

    Registrant's Address : No. 15 Shuangfeng Road, Fotang, Yiwu, Zhejiang 322002, China

    Initial Date of Registration : 2025-11-26

    Latest Date of Registration : 2025-11-26

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    NDC API

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    01

    Honour Lab Limited

    India
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    CPhI Japan
    Not Confirmed
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    MACITENTAN

    NDC Package Code : 69037-0030

    Start Marketing Date : 2013-10-18

    End Marketing Date : 2027-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    Aurobindo Pharma Limited

    India
    CPhI Japan
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 59651-122

    Start Marketing Date : 2024-01-05

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Lonza AG

    Switzerland
    CPhI Japan
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    Lonza AG

    Switzerland
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 49187-0823

    Start Marketing Date : 2013-10-18

    End Marketing Date : 2026-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Lonza AG

    Switzerland
    CPhI Japan
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    Lonza AG

    Switzerland
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    MACITENTAN

    NDC Package Code : 49187-0822

    Start Marketing Date : 2013-10-18

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    MSN Life Sciences Private Limited

    India
    CPhI Japan
    Not Confirmed
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    MSN Life Sciences Private Limited

    India
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 69766-006

    Start Marketing Date : 2016-02-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    TAPI Croatia Industries Ltd.

    Croatia
    CPhI Japan
    Not Confirmed
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    TAPI Croatia Industries Ltd.

    Croatia
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 11722-058

    Start Marketing Date : 2015-07-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (100kg/100kg)

    Marketing Category : BULK INGREDIENT

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    07

    MYLAN LABORATORIES LIMITED

    U.S.A
    CPhI Japan
    Not Confirmed
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    MYLAN LABORATORIES LIMITED

    U.S.A
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 65015-872

    Start Marketing Date : 2017-10-09

    End Marketing Date : 2026-12-01

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

    Marketing Category : BULK INGREDIENT

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    08

    Viyash Life Sciences Private Limite...

    India
    CPhI Japan
    Not Confirmed
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    Viyash Life Sciences Private Limite...

    India
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    CPhI Japan
    Not Confirmed
    • fda
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    MACITENTAN

    NDC Package Code : 82245-0117

    Start Marketing Date : 2013-10-18

    End Marketing Date : 2027-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Zhejiang Ausun Pharmaceutical Co., ...

    China
    CPhI Japan
    Not Confirmed
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    Zhejiang Ausun Pharmaceutical Co., ...

    China
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    CPhI Japan
    Not Confirmed
    • fda
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    MACITENTAN

    NDC Package Code : 76397-014

    Start Marketing Date : 2020-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    10

    Zhejiang Ausun Pharmaceutical Co., ...

    China
    CPhI Japan
    Not Confirmed
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    Zhejiang Ausun Pharmaceutical Co., ...

    China
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    CPhI Japan
    Not Confirmed
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    MACITENTAN

    NDC Package Code : 76397-044

    Start Marketing Date : 2025-04-27

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    Honour Lab Limited

    India
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...

    Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Through Honour Synthesis and Honour Specialty, it delivers innovative solutions leveraging chemistry expertise. Its team of over 2,500 professionals partners with pharmaceutical, biotech, and specialty industries worldwide to develop practical, scalable solutions. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    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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    Macitentan

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    LGM Pharma CB

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    03

    Metrochem API Private Limited

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

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

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    04

    HRV Pharma

    India
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    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    HRV Global Life Sciences

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    05

    TAPI Technology & API Services

    Israel
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

    Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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    06

    Maithri Drugs

    India
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    AACR Annual meeting
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    Virtual BoothMaithri Drugs: Dedicated to your API needs.

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    Macitentan

    About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

    Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    07

    ApiSyn

    India
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    CPhI Japan
    Attending
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    Virtual BoothApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.

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    About the Company : Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino acids across two dedica...

    Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino acids across two dedicated manufacturing facilities. Accredited to ISO 9001:2015 and WHO cGMP, with US DMF and CEP filings, ApiSyn delivers regulatory-compliant, high-quality products supported by robust documentation, strong R&D capabilities, and advanced infrastructure. Note: Products will not be supplied where this conflicts with existing patents. Products under patent are offered for R&D purposes only, with final responsibility resting with the buyer.
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    08

    Haohong (Qihe) Pharmaceutical Techn...

    China
    AACR Annual meeting
    Not Confirmed
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    Haohong (Qihe) Pharmaceutical Techn...

    China
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    Not Confirmed
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    Macitentan

    About the Company : Haohong (Qihe) Pharmaceutical Technology Co., Ltd., based in Qihe, Shandong, specializes in the R\&D and custom production of innovative APIs and intermediates. ISO 9001:2015 certi...

    Haohong (Qihe) Pharmaceutical Technology Co., Ltd., based in Qihe, Shandong, specializes in the R\&D and custom production of innovative APIs and intermediates. ISO 9001:2015 certified, Haohong operates with a skilled R\&D team and advanced testing capabilities. With production bases in Liaocheng and Qihe, the company has a total capacity of 3,000 tons annually. Guided by the values of truth-seeking, innovation, and integrity, Haohong is committed to delivering quality and reliability to customers worldwide.
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    09

    KIVIPharm

    China
    AACR Annual meeting
    Not Confirmed
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    KIVIPharm

    China
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    AACR Annual meeting
    Not Confirmed
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    Macitentan

    About the Company : Kivipharm was established in 1973. After 40 years development, this company become one of the leading manufacturer of aseptic pharmaceutical products in china. Our products was exp...

    Kivipharm was established in 1973. After 40 years development, this company become one of the leading manufacturer of aseptic pharmaceutical products in china. Our products was exported to more than 30 countries from Africa、Middle East、Russia and former CIS countries、South America and South East Asia. Our newly expanded facilities can support our increasing both by markets and by products.
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    10

    Laurus Labs

    India
    AACR Annual meeting
    Not Confirmed
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    Laurus Labs

    India
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    Not Confirmed
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    Macitentan

    About the Company : Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Ph...

    Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus Labs also manufactures APIs in oncology and other therapeutic areas. Its strategic and early investments in R&D and manufacturing infrastructure have enabled it to become one of the leading suppliers of APIs in the ARV therapeutic area. Out of Ten largest generic pharmaceutical companies in the world, by revenues, are our customers.
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    Drugs in Development

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    Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

    Details:

    Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I).


    Lead Product(s): Macitentan,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsumit-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 19, 2025

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    01

    Alembic Pharmaceuticals Limited

    India
    arrow
    AACR Annual meeting
    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed
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    Lead Product(s) : Macitentan,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

    Details : Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I).

    Product Name : Opsumit-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 19, 2025

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    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details:

    Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsynvi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2024

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    02

    Johnson & Johnson Innovative Medicine

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    AACR Annual meeting
    Not Confirmed
    • fda
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.

    Product Name : Opsynvi

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 30, 2024

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    EU Approves Yuvanci for Pulmonary Arterial Hypertension Treatment

    Details:

    Yuvanci (macitentan) is a ETA/ETB inhibitor small molecule drug candidate, which is indicated in combination with tadalafil for the treatment of pulmonary arterial hypertension in adult.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Yuvanci

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2024

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    03

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    EU Approves Yuvanci for Pulmonary Arterial Hypertension Treatment

    Details : Yuvanci (macitentan) is a ETA/ETB inhibitor small molecule drug candidate, which is indicated in combination with tadalafil for the treatment of pulmonary arterial hypertension in adult.

    Product Name : Yuvanci

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 30, 2024

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    Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg

    Details:

    Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2024

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    04

    Humanis

    Turkey
    arrow
    AACR Annual meeting
    Not Confirmed

    Humanis

    Turkey
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadala...

    Details : Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 14, 2024

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    Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/...

    Details:

    Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2024

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    05

    Humanis

    Turkey
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    Not Confirmed

    Humanis

    Turkey
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynviÂ...

    Details : Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 14, 2024

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    J&J Receives Positive CHMP Opinion for Yuvanci® in Pulmonary Arterial Hypertension

    Details:

    Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 26, 2024

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    06

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    J&J Receives Positive CHMP Opinion for Yuvanci® in Pulmonary Arterial Hypertension

    Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 26, 2024

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    FDA Approves OPSYNVI® As First Once-Daily Combination Therapy for PAH

    Details:

    Opsynvi is a combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 inhibitor), approved for adults with pulmonary arterial hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsynvi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 22, 2024

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    07

    Johnson & Johnson Innovative Medicine

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Approves OPSYNVI® As First Once-Daily Combination Therapy for PAH

    Details : Opsynvi is a combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 inhibitor), approved for adults with pulmonary arterial hypertension.

    Product Name : Opsynvi

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 22, 2024

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    Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

    Details:

    Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Treprostinil Sodium,Tadalafil,Sildenafil Citrate,Ambrisentan,Bosentan Hydrate,Macitentan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 19, 2024

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    08

    AOP Orphan

    Austria
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    AACR Annual meeting
    Not Confirmed

    AOP Orphan

    Austria
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    Lead Product(s) : Treprostinil Sodium, Tadalafil, Sildenafil Citrate, Ambrisentan, Bosentan Hydrate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Gro...

    Details : Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 19, 2024

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    Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) ...

    Details:

    ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 26, 2023

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    09

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking...

    Details : ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 26, 2023

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    Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for T...

    Details:

    The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 30, 2023

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    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet...

    Details : The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 30, 2023

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    INTERMEDIATE SUPPLIERS

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    01

    ApiSyn

    India
    CPhI Japan
    Attending
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    5-(4-bromophenyl)-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino aci...

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    02

    Ami Organics Private Limited

    India
    AACR Annual meeting
    Not Confirmed
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    Ami Organics Private Limited

    India
    AACR Annual meeting
    Not Confirmed
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    5-(4-BROMOPHENYL)-4,6-DICHLOROPYRIMIDINE

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    03

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    5-(4-bromophenyl)-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    04

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    2-(4-Bromophenyl)-propanedioic acid, 1,3-mdiethyl ...

    CAS Number : 149506-35-4

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    05

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
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    n-Propyl sulfamide

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    5-(4-Bromophenyl)-4,6-dichloropyrimidine

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    5-4-bromophenyl-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

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    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 
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    Company : Actelion Pharma

    Macitentan

    Drug Cost (USD) : 541,974,553

    Year : 2019

    Prescribers : 6795

    Prescriptions : 53300

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    Company : Actelion Pharma

    Macitentan

    Drug Cost (USD) : 468,822,598

    Year : 2018

    Prescribers : 6107

    Prescriptions : 49750

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    Company : Actelion Pharma

    Macitentan

    Drug Cost (USD) : 400,407,099

    Year : 2017

    Prescribers : 5514

    Prescriptions : 45670

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    Company : Actelion Pharma

    Macitentan

    Drug Cost (USD) : 343,677,462

    Year : 2016

    Prescribers : 5338

    Prescriptions : 43812

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    Annual Reports

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2020 Revenue in Millions : 1,639

    2019 Revenue in Millions : 1,327

    Growth (%) : 24

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2021 Revenue in Millions : 1,819

    2020 Revenue in Millions : 1,639

    Growth (%) : 11

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2022 Revenue in Millions : 1,783

    2021 Revenue in Millions : 1,819

    Growth (%) : -2

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2023 Revenue in Millions : 1,973

    2022 Revenue in Millions : 1,783

    Growth (%) : 11

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2024 Revenue in Millions : 2,184

    2023 Revenue in Millions : 1,973

    Growth (%) : 11

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2017 Revenue in Millions : 573

    2016 Revenue in Millions : 878

    Growth (%) : -35

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2018 Revenue in Millions : 1,215

    2017 Revenue in Millions : 573

    Growth (%) : 112%

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    Johnson & Johnson

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2019 Revenue in Millions : 1,327

    2018 Revenue in Millions : 1,215

    Growth (%) : 9

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    Actelion

    Macitentan

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2016 Revenue in Millions : 823

    2015 Revenue in Millions : 511

    Growth (%) : 61

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    Market Place

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    APIs

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    Macitentan API needed in Turkey [ENA24272]
    A group of companies that focuses on the manufacturing, development & distribution of various finished formulations is looking for suppliers of Macitentan API for development purposes. The suppliers must support this enquiry with CoA.
    10 Oct 2025

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    10 Oct 2025

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    Reply Comment (4)

    10 Oct 2025

    Macedonia.png
    Ph. Eur. & USP Grade Macitentan API needed in Macedonia [ENA21822]
    A company that focuses on manufacturing of various finished formulations and food supplements is looking for suppliers of Ph. Eur. & USP Grade Macitentan API for both development and commercial purposes. The required quantity is 20 kg - 30 kg. The suppliers must support this enquiry with DMF, GMP & CoA.
    22 Jan 2025

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    22 Jan 2025

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    22 Jan 2025

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    Macitentan (5 kg - 10 kg/ annum) API needed in Japan [ENA11172]
    A company that deals in the development, manufacturing & sales of pharmaceutical products is looking for suppliers of Macitentan (5 kg - 10 kg/ annum) API for development purpose.
    20 Aug 2021

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    20 Aug 2021

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    20 Aug 2021

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    Various APIs needed in Russia [ENA09605]
    A top Russian pharmaceutical company that is a leader in the spheres of the synthesis of innovative substances and modern dosage forms is looking for suppliers of Various APIs for development purposes. The required quantity is 100 g and 1 kg for each. The suppliers must support this enquiry with CoA. 1. Iloprost API 2. Nadroparin Calcium API 3. Ambrisentan API 4. Dabigatran Etexilate API 5. Riociguat API 6. Eltrombopag API 7. Rivaroxaban API 8. Ticagrelor API 9. Macitentan API
    29 Jan 2021

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    29 Jan 2021

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    Reply Comment (14)

    29 Jan 2021

    Iran.png
    Macitentan (12 kg) API needed in Iran [ENA09460]
    A pharmaceutical company that aims to supply medicine, medical equipment and quality pharmaceutical supplies is looking for suppliers of Macitentan API for development purposes and later commercial purposes. The required quantity is 12 kg for commercial purposes.
    11 Jan 2021

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    11 Jan 2021

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    11 Jan 2021

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    Macitentan (50 g) API needed in India [ENA08762]
    A pharmaceutical company that deals in the manufacturing of tablets, capsules & powder sachets is looking for suppliers of Macitentan (50 g) API.
    08 Oct 2020

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    08 Oct 2020

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    Reply Comment (7)

    08 Oct 2020

    Iran.png
    Various APIs needed in Iran [ENA08108]
    A pharmaceutical manufacturing company that specializes in tablets, capsules & suspensions is looking for suppliers of Various APIs. The required quantity is 1 kg for each. 1. Abiraterone 2. Bicalutamide 3. Busulfan 4. Capecitabine 5. Carbamazepine 6. Chlorambucil 7. Clonazepam 8. Colchicine 9. Cyclophosphamide 10. Dasatinib 11. Erlotinib 12. Everolimus 13. Exemestane 14. Flutamide 15. Imatinib 16. Leflunomide 17. Lenalidomide 18. Lomustine 19. Macitentan 20. Mercaptopurine 21. Methotrexate 22. Nilotinib 23. Oxcarbazepine 24. Paroxetine 25. Risperidone 26. Sorafenib 27. Sunitinib 28. Temozolomide 29. Teriflunomide 30. Thalidomide 31. Topiramate 32. Valproate 33. Vinorelbine 34. Voriconazole
    30 Jul 2020

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    30 Jul 2020

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    30 Jul 2020

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    Macitentan and Alpha Lipoic Acid APIs needed in Vietnam [ENA05333]
    One of the fastest growing pharmaceutical companies in Vietnam offering a wide range of finished products is looking for suppliers of APIs mentioned below. 1. Macitentan 2. BP/EP grade Alpha Lipoic Acid- 20 kg.
    03 Oct 2019

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    03 Oct 2019

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    03 Oct 2019

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    FDF DOSSIERS

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    Tender// Various Finished Dosage Formulations needed in Moldova [ENA14424]
    Center For Centralized Public Procurement In Health Moldova is looking for supplies of Various Finished Dosage Formulations. The deadline is 8-Sept-2022. 1. Macitentan (10 mg) Tablets. The required quantity is 500 units. 2. Selexipag (200 mcg) Tablets. The required quantity is 600 units. 3. Selexipag (400 mcg) Tablets. The required quantity is 120 units. 4. Selexipag (800 mcg) Tablets. The required quantity is 480 units. 5. Sildenafil (50 mg) Tablets. The required quantity is 940 units.
    22 Jul 2022

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    22 Jul 2022

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    22 Jul 2022

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    Tender// Various Finished Dosage Formulations needed in Poland [ENA10510]
    Upper Silesian Medical Center prof. Leszek Giec of the Medical University of Silesia in Katowice is looking for supplies of Various Finished Dosage Formulations. The suppliers must support this tender with ESPD. The deadline is 8-June-2021. 1. Infliximab (100 mg) Injections. The required quantity is 400 units. 2. Interferon Beta-1A (44 mcg/ 0.5 ml x 4 cartridges and 1.5 ml) Cartridge. The required quantity is 240 units. 3. Macitentan (10 mg) Tablets. The required quantity is 380 units. 4. Epoprostenol (0.5 mg and 1.5 mg) Solution for infusion. The required quantity is 30 units and 3,000 units respectively. 5. Interferon Beta-1A (30 mcg/ 0.5 ml) Powder + solvent. The required quantity is 360 units.
    27 May 2021

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    27 May 2021

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    27 May 2021

    Colombia.png
    Various finished formulations needed in Colombia [ENA05336]
    A Colombian company incorporated in April 2006 by professionals in the area of health, sales, and marketing of the pharmaceutical industry is looking for suppliers of various finished formulations mentioned below: 1. Abiraterone (250 mg) tablets 2. Abiraterone (500 mg) tablets 3. Bilastine (20 mg) tablets 4. Buprenorphine 5. Eltrombopag 6. Fingolimod 7. Macitentan 8. Miglustat 9. Tapentadol 10. Ticagrelor.
    03 Oct 2019

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    03 Oct 2019

    PharmaCompass
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    Patents & EXCLUSIVITIES

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    US Patents

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    ACTELION

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    ACTELION

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    Patent Expiration Date : 2026-09-11

    MACITENTAN

    US Patent Number : 10946015

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204410

    Patent Use Code : U-1445

    Delist Requested :

    Patent Use Description : METHOD OF TREATING PUL...

    Patent Expiration Date : 2026-09-11

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    ACTELION

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    Not Confirmed

    Patent Expiration Date : 2028-10-04

    MACITENTAN

    US Patent Number : 8367685

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204410

    Patent Use Code : U-1445

    Delist Requested :

    Patent Use Description : METHOD OF TREATING PUL...

    Patent Expiration Date : 2028-10-04

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    ACTELION

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    ACTELION

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    Patent Expiration Date : 2025-12-05

    MACITENTAN

    US Patent Number : 7094781

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-12-05

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    ACTELION

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    ACTELION

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    Patent Expiration Date : 2029-10-18

    MACITENTAN

    US Patent Number : 8268847*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2029-10-18

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    ACTELION

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    ACTELION

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    Patent Expiration Date : 2026-06-05

    MACITENTAN

    US Patent Number : 7094781*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-06-05

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    ACTELION

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    ACTELION

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    Patent Expiration Date : 2029-04-04

    MACITENTAN

    US Patent Number : 8367685*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2029-04-04

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    07

    ACTELION

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    Not Confirmed

    ACTELION

    U.S.A
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    CPhI Japan
    Not Confirmed

    Patent Expiration Date : 2027-11-29

    MACITENTAN

    US Patent Number : 9265762*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-11-29

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    ACTELION

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    Not Confirmed

    ACTELION

    U.S.A
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    CPhI Japan
    Not Confirmed

    Patent Expiration Date : 2027-03-11

    MACITENTAN

    US Patent Number : 10946015*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-03-11

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    ACTELION

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    Not Confirmed

    ACTELION

    U.S.A
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    CPhI Japan
    Not Confirmed

    Patent Expiration Date : 2029-04-18

    MACITENTAN

    US Patent Number : 8268847

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204410

    Patent Use Code : U-1446

    Delist Requested :

    Patent Use Description : METHOD OF TREATING PUL...

    Patent Expiration Date : 2029-04-18

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    ACTELION

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    ACTELION

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    CPhI Japan
    Not Confirmed

    Patent Expiration Date : 2027-05-29

    MACITENTAN

    US Patent Number : 9265762

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204410

    Patent Use Code : U-1820

    Delist Requested :

    Patent Use Description : METHOD OF TREATING PUL...

    Patent Expiration Date : 2027-05-29

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    REF. STANDARDS & IMPURITIES

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    USP

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    Virtual BoothUSP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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    Macitentan Amine

    CAS Number : 1433875-21-8

    Quantity Per Vial :

    Price ($) : 850

    Catalog Number : 1A05690

    Current Lot :

    Previous Lot :

    NDC Code :

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    Macitentan Sulfamide Dimer

    CAS Number : 2089065-77-8

    Quantity Per Vial :

    Price ($) : 1100

    Catalog Number : 1A05660

    Current Lot :

    Previous Lot :

    NDC Code :

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    Despropyl Macitentan

    CAS Number : 1103522-45-7

    Quantity Per Vial :

    Price ($) :

    Catalog Number : 1A05650

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    NDC Code :

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    ABOUT THIS PAGE

    Looking for 441798-33-0 / Macitentan API manufacturers, exporters & distributors?

    Macitentan manufacturers, exporters & distributors 1

    23

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Macitentan manufacturer or Macitentan supplier.

    API | Excipient name

    Macitentan

    Synonyms

    441798-33-0, Opsumit, Act-064992, Act 064992, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide, Act064992

    Cas Number

    441798-33-0

    Unique Ingredient Identifier (UNII)

    Z9K9Y9WMVL

    About Macitentan

    Macitentan is an orally available dual endothelin receptor (ETR) antagonist with potential antihypertensive and antineoplastic activity. Upon administration, macitentan and its metabolites block the binding of endothelin isoform 1 (ET-1) to type-A and type-B ETR on both the tumor cells and the endothelial cells in the tumor vasculature. This prevents ET-1 mediated signaling transduction which may decrease tumor cell proliferation, progression, and angiogenesis in tumor tissue. ET-1, a potent vasoconstrictor that plays an important role in inflammation and tissue repair, is, together with its receptors, overexpressed varyingly in many tumor cell types.

    opsumit Manufacturers

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

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

    opsumit Suppliers

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

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

    opsumit USDMF

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

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

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

    opsumit JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The opsumit Drug Master File in Japan (opsumit JDMF) empowers opsumit API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the opsumit JDMF during the approval evaluation for pharmaceutical products. At the time of opsumit JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of opsumit suppliers with JDMF on PharmaCompass.

    opsumit KDMF

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

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

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

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

    opsumit WC

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

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

    opsumit NDC

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

    Finished drug products

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

    Unfinished drugs

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

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

    Compounded drug products

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

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

    opsumit GMP

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

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

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

    opsumit CoA

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

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

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

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