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1H-1-Benzazepine-1-acetic acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, monohydrochloride, (S-(R,R))-

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 17 USDMF, 9 CEP/COS, 2 JDMF, 7 EU WC, 13 NDC API, 8 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

165 FDF Dossiers, 150 FDA Orange Book, 8 Canada, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 12 DKSH, 5 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 36 BASF, 2 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 35 Thickeners and Stabilizers, 34 Solubilizers, 33 Direct Compression, 32 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 29 Granulation, 25 Lubricants & Glidants, 23 Topical, 20 Film Formers & Plasticizers, 17 Parenteral, 14 Co-Processed Excipients, 13 Emulsifying Agents, 9 Empty Capsules, 9 Taste Masking, 9 Chewable & Orodispersible Aids, 7 Surfactant & Foaming Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

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2 US Medicaid Prescriptions, 20 Regulatory FDF Prices

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2 APIs

2 APIs

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3 EDQM, 1 USP, 1 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Nuray Chemicals Private Limited	India	NURAY CHEMICALS PRIVATE LTD	36768	BENAZEPRIL HYDROCHLORIDE USP	2022-02-07	Active	II	Complete	2022-10-28	2022-02-11
28/03/2025	Aarti Pharmalabs	India	AARTI PHARMALABS LTD	20097	BENAZEPRIL HYDROCHLORIDE	2006-12-27	Active	II	Complete	2024-01-26	2023-10-05

1H-1-Benzazepine-1-acetic Acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, Monohydrochloride, (S-(R*,R*))-

1H-1-Benzazepine-1-acetic acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, monohydrochloride, (S-(R*,R*))-

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers

17 USDMF

9 CEP/COS

2 JDMF

7 EU WC

13 NDC API

8 Listed Suppliers

$ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

165 FDF Dossiers

150 FDA Orange Book

8 Canada

7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 10MG BASE;20MG

CAPSULE;ORAL - EQ 10MG BASE;40MG

CAPSULE;ORAL - EQ 2.5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;20MG

CAPSULE;ORAL - EQ 5MG BASE;40MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

12 DKSH

5 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

4 ACG Worldwide

6 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

36 BASF

2 Clariant

11 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

38 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

20 Roquette

16 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders

56 Coating Systems & Additives

35 Thickeners and Stabilizers

34 Solubilizers

1H-1-Benzazepine-1-acetic Acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, Monohydrochloride, (S-(R,R))-

1H-1-Benzazepine-1-acetic acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, monohydrochloride, (S-(R,R))-

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons