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Macitentan
FDA Orange Book

PharmaCompass Sponsored Ads

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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With Fermion, start the journey of your innovative API.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Temad- We think of world-class quality.

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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

65 Drugs in Development

65 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 Controlled & Modified Release, 12 Lubricants & Glidants, 11 Parenteral, 9 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Topical, 5 Rheology Modifiers, 5 Emulsifying Agents, 3 Taste Masking, 3 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 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 Controlled & Modified Release
12 Lubricants & Glidants
11 Parenteral
9 Co-Processed Excipients
7 Film Formers & Plasticizers
6 Topical
5 Rheology Modifiers
5 Emulsifying Agents
3 Taste Masking
3 Surfactant & Foaming Agents
3 Chewable & Orodispersible Aids
3 API Stability Enhancers
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

7 APIs, 3 FDF Dossiers

7 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) : 11,179 Xls

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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

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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

The MedTech Conference

Not Confirmed

ALEMBIC

The MedTech Conference

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

The MedTech Conference

Not Confirmed

APOTEX

The MedTech Conference

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

The MedTech Conference

Not Confirmed

AUROBINDO PHARMA LTD

The MedTech Conference

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

The MedTech Conference

Not Confirmed

ACTELION

The MedTech Conference

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

The MedTech Conference

Not Confirmed

MSN

The MedTech Conference

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

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Digital Content

Corporate PDF

06

RHODES PHARMS

The MedTech Conference

Not Confirmed

RHODES PHARMS

The MedTech Conference

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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 :

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07

SUN PHARM

The MedTech Conference

Not Confirmed

SUN PHARM

The MedTech Conference

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

The MedTech Conference

Not Confirmed

TORRENT

The MedTech Conference

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

The MedTech Conference

Not Confirmed

ZYDUS LIFESCIENCES

The MedTech Conference

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

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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