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Macitentan
FDA Orange Book

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Veranova: A CDMO that manages complexity with confidence.

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Macitentan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 14 USDMF, 4 JDMF, 5 EU WC, 5 KDMF, 11 NDC API, 27 Listed Suppliers

39 API Suppliers
14 USDMF
4 JDMF
5 EU WC
5 KDMF
11 NDC API
27 Listed Suppliers

DEVELOPMENTS

59 Drugs in Development

59 Drugs in Development

INTERMEDIATES

16 Intermediate Suppliers

16 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

78 FDF Dossiers, 12 FDA Orange Book, 50 Europe, 3 Canada, 6 Australia, 1 South Africa, 6 Listed Dossiers

78 FDF Dossiers
12 FDA Orange Book
50 Europe
3 Canada
6 Australia
1 South Africa
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 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, 1 Gloria Interchem, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 13 Kerry, 2 Keval Exports, 10 Microlex e.U, 1 Nanjing Bold Chemical, 1 Neelkanth MineChem, 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, 18 Coating Systems & Additives, 17 Granulation, 17 Solubilizers, 16 Direct Compression, 14 Thickeners and Stabilizers, 14 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 12 Controlled & Modified Release, 11 Parenteral, 10 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Emulsifying Agents, 4 Topical, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 3 Taste Masking, 3 Surfactant & Foaming Agents, 3 Rheology Modifiers

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 46 News #PharmaBuzz

1 Data Compilation #PharmaFlow
46 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

1 US Medicaid Prescriptions
1 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

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12 All

01 1ACTELION

02 1ALEMBIC

03 1APOTEX

04 1AUROBINDO PHARMA LTD

05 1LAURUS

06 1MSN

07 1MYLAN

08 1RHODES PHARMS

09 1SEASONS BIOTECH

10 1SUN PHARM

11 1TORRENT

12 1ZYDUS LIFESCIENCES

filter Dosage Reset all filters

12 All

01 12TABLET;ORAL

filter Regulatory Info Reset all filters

12 All

01 5DISCN

02 6RX

03 1Blank

filter Brand Name Reset all filters

12 All

01 11MACITENTAN

02 1OPSUMIT

filter RLD Reset all filters

12 All

01 10No

02 1Yes

03 1Blank

List of Suppliers

Product Main Page

01

ALEMBIC

AACR Annual meeting

Not Confirmed

ALEMBIC

AACR 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

AACR Annual meeting

Not Confirmed

APOTEX

AACR 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

AACR Annual meeting

Not Confirmed

AUROBINDO PHARMA LTD

AACR Annual meeting

Not Confirmed

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-04-18

Application Number : 211198

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ACTELION

AACR Annual meeting

Not Confirmed

ACTELION

AACR 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

LAURUS

AACR Annual meeting

Not Confirmed

LAURUS

AACR Annual meeting

Not Confirmed

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-11-05

Application Number : 211120

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

MSN

AACR Annual meeting

Not Confirmed

MSN

AACR 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

07

SEASONS BIOTECH

AACR Annual meeting

Not Confirmed

SEASONS BIOTECH

AACR 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 : 2025-12-03

Application Number : 211026

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SUN PHARM

AACR Annual meeting

Not Confirmed

SUN PHARM

AACR 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

09

TORRENT

AACR Annual meeting

Not Confirmed

TORRENT

AACR 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

10

MYLAN

AACR Annual meeting

Not Confirmed

MYLAN

AACR 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 : 2025-12-03

Application Number : 211161

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.