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Simvastatin

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 36 USDMF, 41 CEP/COS, 7 JDMF, 8 EU WC, 45 KDMF, 12 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

989 FDF Dossiers, 140 FDA Orange Book, 572 Europe, 65 Canada, 52 Australia, 88 South Africa, 72 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- 40MG, TABLET;ORAL - 5MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 20MG/5ML, SUSPENSION;ORAL - 40MG/5ML, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL -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, 6 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 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, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 30 Thickeners and Stabilizers, 29 Controlled & Modified Release, 26 Direct Compression, 24 Granulation, 20 Lubricants & Glidants, 19 Solubilizers, 19 Disintegrants & Superdisintegrants, 18 Film Formers & Plasticizers, 15 Topical, 12 Taste Masking, 11 Co-Processed Excipients, 10 Rheology Modifiers, 7 Parenteral, 6 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 525 Regulatory FDF Prices, 10 Annual Reports

MARKET PLACE

19 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 4 JP, 11 Others

ANALYTICAL

7 BioAnalytical Methods

7 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	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	14599	SIMVASTATIN	1999-11-29	Active	II	N/A
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	25024	SIMVASTATIN (ETHANOL PROCESS)	2011-06-08	Active	II	Complete	2014-01-13	2012-11-13

Simvastatin

Simvastatin

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

95 API Suppliers

36 USDMF

41 CEP/COS

7 JDMF

8 EU WC

45 KDMF

12 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

989 FDF Dossiers

140 FDA Orange Book

572 Europe

65 Canada

52 Australia

88 South Africa

72 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

6 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

2 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

26 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

4 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

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

11 Sigachi Industries

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

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