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Macitentan
FDA Orange Book

PharmaCompass Sponsored Ads

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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pharmacompass-2-m-2025-10-20

Macitentan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 14 USDMF, 5 EU WC, 1 KDMF, 10 NDC API, 26 Listed Suppliers, $ API Reference Price

37 API Suppliers
14 USDMF
5 EU WC
1 KDMF
10 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

38 FDF Dossiers, 9 FDA Orange Book, 16 Europe, 2 Canada, 4 Australia, 1 South Africa, 6 Listed Dossiers

38 FDF Dossiers
9 FDA Orange Book
16 Europe
2 Canada
4 Australia
1 South Africa
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 4 DKSH, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 2 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 11 BASF, 1 CD Formulation, 5 Corel Pharma Chem, 5 DFE Pharma, 10 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 13 Kerry, 2 Keval Exports, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 11 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

35 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 17 Granulation, 17 Solubilizers, 16 Direct Compression, 15 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 12 Controlled & Modified Release, 11 Parenteral, 9 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Topical, 5 Rheology Modifiers, 5 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 3 Taste Masking, 3 Surfactant & Foaming Agents, 2 Coloring Agents

35 Fillers, Diluents & Binders
20 Coating Systems & Additives
17 Granulation
17 Solubilizers
16 Direct Compression
15 Thickeners and Stabilizers
15 Disintegrants & Superdisintegrants
12 Lubricants & Glidants
12 Controlled & Modified Release
11 Parenteral
9 Co-Processed Excipients
7 Film Formers & Plasticizers
6 Topical
5 Rheology Modifiers
5 Emulsifying Agents
3 Chewable & Orodispersible Aids
3 API Stability Enhancers
3 Taste Masking
3 Surfactant & Foaming Agents
2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 42 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
42 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 2 Regulatory FDF Prices, 9 Annual Reports

1 US Medicaid Prescriptions
2 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

8 APIs, 3 FDF Dossiers

8 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 2 US Exclusivities, 5 Health Canada Patents

10 US Patents
2 US Exclusivities
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 1 Others

3 USP
1 Others

$ API Ref.Price (USD/KG) : 11,229 Xls

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9 All

01 1ACTELION

02 1ALEMBIC

03 1APOTEX

04 1AUROBINDO PHARMA LTD

05 1MSN

06 1RHODES PHARMS

07 1SUN PHARM

08 1TORRENT

09 1ZYDUS LIFESCIENCES

filter Dosage Reset all filters

9 All

01 9TABLET;ORAL

filter Regulatory Info Reset all filters

9 All

01 4DISCN

02 4RX

03 1Blank

filter Brand Name Reset all filters

9 All

01 8MACITENTAN

02 1OPSUMIT

filter RLD Reset all filters

9 All

01 7No

02 1Yes

03 1Blank

List of Suppliers

Product Main Page

01

ALEMBIC

AIChE Annual Meeting

Not Confirmed

ALEMBIC

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-18

Application Number : 211128

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

APOTEX

AIChE Annual Meeting

Not Confirmed

APOTEX

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2024-01-09

Application Number : 211195

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

AUROBINDO PHARMA LTD

AIChE Annual Meeting

Not Confirmed

AUROBINDO PHARMA LTD

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-04-18

Application Number : 211198

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ACTELION

AIChE Annual Meeting

Not Confirmed

ACTELION

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : OPSUMIT

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2013-10-18

Application Number : 204410

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

MSN

AIChE Annual Meeting

Not Confirmed

MSN

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-20

Application Number : 211136

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

RHODES PHARMS

AIChE Annual Meeting

Not Confirmed

RHODES PHARMS

AIChE Annual Meeting

Not Confirmed

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RLD :

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 214112

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

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07

SUN PHARM

AIChE Annual Meeting

Not Confirmed

SUN PHARM

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-26

Application Number : 211123

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

TORRENT

AIChE Annual Meeting

Not Confirmed

TORRENT

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2024-08-05

Application Number : 211107

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

ZYDUS LIFESCIENCES

AIChE Annual Meeting

Not Confirmed

ZYDUS LIFESCIENCES

AIChE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2021-04-06

Application Number : 211224

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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