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Enalapril Maleate

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 17 USDMF, 14 CEP/COS, 4 JDMF, 5 EU WC, 10 KDMF, 10 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

769 FDF Dossiers, 94 FDA Orange Book, 456 Europe, 46 Canada, 34 Australia, 45 South Africa, 94 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET;ORAL - 10MG;25MG, TABLET;ORAL - 5MG;12.5MG, FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 23 Direct Compression, 21 Controlled & Modified Release, 20 Granulation, 18 Lubricants & Glidants, 17 Disintegrants & Superdisintegrants, 16 Thickeners and Stabilizers, 11 Co-Processed Excipients, 11 Taste Masking, 9 Film Formers & Plasticizers, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Coloring Agents, 2 Parenteral, 2 Topical, 1 Surfactant & Foaming Agents, 1 Solubilizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 29 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 385 Regulatory FDF Prices

MARKET PLACE

21 APIs, 12 FDF Dossiers

PATENTS & EXCLUSIVITIES

29 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 JP, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

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	Medichem S.A	Spain	MEDICHEM SA	13055	ENALAPRIL MALEATE	1998-06-29	Active	II	N/A
28/03/2025	Neuland Laboratories	India	NEULAND LABORATORIES LTD	15434	ENALAPRIL MALEATE	2001-05-15	Active	II	N/A

Enalapril Maleate

Enalapril Maleate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers

17 USDMF

14 CEP/COS

4 JDMF

5 EU WC

10 KDMF

10 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

769 FDF Dossiers

94 FDA Orange Book

456 Europe

46 Canada

34 Australia

45 South Africa

94 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 2.5MG

TABLET;ORAL - 20MG

TABLET;ORAL - 5MG

TABLET;ORAL - 10MG;25MG

TABLET;ORAL - 5MG;12.5MG

FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

5 SPI Pharma

5 DKSH

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

5 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

2 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

9 BASF

1 Bioplus Life Sciences

10 Corel Pharma Chem

6 DFE Pharma

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Novo Excipients

1 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders

45 Coating Systems & Additives

23 Direct Compression

21 Controlled & Modified Release

20 Granulation

18 Lubricants & Glidants

17 Disintegrants & Superdisintegrants

16 Thickeners and Stabilizers

FOR SOLUTION;ORAL - 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons