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Pravastatin

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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 16 USDMF, 12 CEP/COS, 10 JDMF, 3 EU WC, 9 KDMF, 5 NDC API, 9 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

448 FDF Dossiers, 78 FDA Orange Book, 234 Europe, 51 Canada, 42 Australia, 27 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 24 SPI Pharma, 5 DKSH, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 39 Direct Compression, 36 Disintegrants & Superdisintegrants, 30 Granulation, 26 Lubricants & Glidants, 24 Controlled & Modified Release, 21 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 18 Taste Masking, 15 Solubilizers, 9 Parenteral, 9 Film Formers & Plasticizers, 9 API Stability Enhancers, 6 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Topical, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

20 News #PharmaBuzz

20 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 228 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 6 JP, 5 Others

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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	Chunghwa Chemical Synthesis & Biotech	Taiwan	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	14235	PRAVASTATIN SODIUM USP	1999-06-24	Inactive	II	N/A
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	14729	PRAVASTATIN SODIUM	2000-02-25	Active	II	Complete	2012-12-24	2012-11-13

Pravastatin

Pravastatin

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

28 API Suppliers

16 USDMF

12 CEP/COS

10 JDMF

3 EU WC

9 KDMF

5 NDC API

9 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

448 FDF Dossiers

78 FDA Orange Book

234 Europe

51 Canada

42 Australia

27 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

24 SPI Pharma

5 DKSH

7 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

6 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

1 ACG Worldwide

2 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

21 BASF

11 Corel Pharma Chem

6 DFE Pharma

10 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

37 Kerry

3 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders

47 Coating Systems & Additives

39 Direct Compression

36 Disintegrants & Superdisintegrants

30 Granulation

26 Lubricants & Glidants

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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