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Simvastatin

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ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 37 USDMF, 42 CEP/COS, 7 JDMF, 7 EU WC, 45 KDMF, 12 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1150 FDF Dossiers, 140 FDA Orange Book, 729 Europe, 70 Canada, 52 Australia, 88 South Africa, 71 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 5 SPI Pharma, 9 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 26 BASF, 2 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 35 Thickeners and Stabilizers, 31 Direct Compression, 29 Granulation, 24 Controlled & Modified Release, 20 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 19 Solubilizers, 17 Film Formers & Plasticizers, 16 Topical, 13 Taste Masking, 10 Parenteral, 10 Co-Processed Excipients, 10 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 50 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 347 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

22 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents

16 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 9 Others

ANALYTICAL

7 BioAnalytical Methods

7 BioAnalytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
31/10/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL	R1-CEP 2013-216 - Rev 03	Simvastatin, Ethanol/acetonitrile process	2022-11-28	Valid	Chemical		1563
31/10/2025	TAPI Technology & API Services	Israel	TAPI NL B.V. Amsterdam NL	CEP 2010-130 - Rev 06	Simvastatin, Ethanol process	2025-09-22	Valid	Chemical		1563

Simvastatin

Simvastatin

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

95 API Suppliers

37 USDMF

42 CEP/COS

7 JDMF

7 EU WC

45 KDMF

12 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1150 FDF Dossiers

140 FDA Orange Book

729 Europe

70 Canada

52 Australia

88 South Africa

71 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SUSPENSION;ORAL - 20MG/5ML

SUSPENSION;ORAL - 40MG/5ML

TABLET;ORAL - 10MG;10MG

TABLET;ORAL - 10MG;20MG

TABLET;ORAL - 10MG;40MG

TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Rochem International Inc

5 SPI Pharma

9 DKSH

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

4 Kirsch Pharma

1 ACG Worldwide

3 Actylis

2 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

1 Avesta Pharma

26 BASF

2 CD Formulation

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

8 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

2 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

10 Sigachi Industries

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons