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Opsumit
FDA Orange Book

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Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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pharmacompass-2-m-2025-11-03

opsumit

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 14 USDMF, 2 JDMF, 5 EU WC, 5 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

38 API Suppliers
14 USDMF
2 JDMF
5 EU WC
5 KDMF
11 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

64 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

46 FDF Dossiers, 12 FDA Orange Book, 19 Europe, 2 Canada, 6 Australia, 1 South Africa, 6 Listed Dossiers

46 FDF Dossiers
12 FDA Orange Book
19 Europe
2 Canada
6 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 Solubilizers, 17 Granulation, 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 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 Solubilizers
17 Granulation
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 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, 45 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
45 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) : 11,116 Xls

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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

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12 All

01 12TABLET;ORAL

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12 All

01 3DISCN

02 8RX

03 1Blank

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12 All

01 11MACITENTAN

02 1OPSUMIT

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12 All

01 10No

02 1Yes

03 1Blank

List of Suppliers

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01

ALEMBIC

BIO Partnering at JPM

Not Confirmed

ALEMBIC

BIO Partnering at JPM

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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

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02

APOTEX

BIO Partnering at JPM

Not Confirmed

APOTEX

BIO Partnering at JPM

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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 :

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03

AUROBINDO PHARMA LTD

BIO Partnering at JPM

Not Confirmed

AUROBINDO PHARMA LTD

BIO Partnering at JPM

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Digital Content

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

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04

ACTELION

BIO Partnering at JPM

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ACTELION

BIO Partnering at JPM

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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

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05

LAURUS

BIO Partnering at JPM

Not Confirmed

LAURUS

BIO Partnering at JPM

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Digital Content

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

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06

MSN

BIO Partnering at JPM

Not Confirmed

MSN

BIO Partnering at JPM

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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

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07

SUN PHARM

BIO Partnering at JPM

Not Confirmed

SUN PHARM

BIO Partnering at JPM

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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

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08

TORRENT

BIO Partnering at JPM

Not Confirmed

TORRENT

BIO Partnering at JPM

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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

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09

MYLAN

BIO Partnering at JPM

Not Confirmed

MYLAN

BIO Partnering at JPM

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 : 2025-12-03

Application Number : 211161

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

SEASONS BIOTECH

Country

BIO Partnering at JPM

Not Confirmed

SEASONS BIOTECH

Country

BIO Partnering at JPM

Not Confirmed

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Country

Virtual Booth

Digital Content

RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-12-03

Application Number : 211026

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Virtual Booth

Digital Content

Website

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.