5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine
FDA Orange Book

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

ACCESS ALL DATA, CHEMISTRY

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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 Controlled & Modified Release, 12 Lubricants & Glidants, 11 Parenteral, 10 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Emulsifying Agents, 4 Topical, 3 Taste Masking, 3 Surfactant & Foaming Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers

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

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 4DISCN

02 7RX

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

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01

ALEMBIC

AMWC Asia-TDAC

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ALEMBIC

AMWC Asia-TDAC

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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

AMWC Asia-TDAC

Not Confirmed

APOTEX

AMWC Asia-TDAC

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2024-01-09

Application Number : 211195

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

AUROBINDO PHARMA LTD

AMWC Asia-TDAC

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AUROBINDO PHARMA LTD

AMWC Asia-TDAC

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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

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04

ACTELION

AMWC Asia-TDAC

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ACTELION

AMWC Asia-TDAC

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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

AMWC Asia-TDAC

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LAURUS

AMWC Asia-TDAC

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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

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06

MSN

AMWC Asia-TDAC

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MSN

AMWC Asia-TDAC

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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

SEASONS BIOTECH

AMWC Asia-TDAC

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SEASONS BIOTECH

AMWC Asia-TDAC

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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 :

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08

SUN PHARM

AMWC Asia-TDAC

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SUN PHARM

AMWC Asia-TDAC

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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

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09

TORRENT

AMWC Asia-TDAC

Not Confirmed

TORRENT

AMWC Asia-TDAC

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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 :

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10

MYLAN

AMWC Asia-TDAC

Not Confirmed

MYLAN

AMWC Asia-TDAC

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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 :

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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.