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Pravastatin

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 16 USDMF, 12 CEP/COS, 9 JDMF, 3 EU WC, 8 KDMF, 4 NDC API, 9 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

442 FDF Dossiers, 78 FDA Orange Book, 234 Europe, 51 Canada, 36 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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 23 SPI Pharma, 3 DKSH, 2 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 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

91 Fillers, Diluents & Binders, 49 Direct Compression, 47 Coating Systems & Additives, 35 Disintegrants & Superdisintegrants, 30 Granulation, 28 Lubricants & Glidants, 25 Controlled & Modified Release, 23 Co-Processed Excipients, 20 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 17 Taste Masking, 14 Solubilizers, 10 API Stability Enhancers, 9 Parenteral, 9 Film Formers & Plasticizers, 6 Emulsifying Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Topical, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

20 NEWS #PharmaBuzz

20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 228 Finished Drug 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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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Chunghwa Chemical Synthesis & Biotech	Taiwan	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	14235	PRAVASTATIN SODIUM USP	1999-06-24	Active	II	N/A
28/10/2024	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INC	17023	PRAVASTATIN SODIUM	2003-12-11	Active	II	N/A

Pravastatin

Pravastatin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers

16 USDMF

12 CEP/COS

9 JDMF

3 EU WC

8 KDMF

4 NDC API

9 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

442 FDF Dossiers

78 FDA Orange Book

234 Europe

51 Canada

36 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

23 SPI Pharma

3 DKSH

2 Jai Radhe Sales

7 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

13 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

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

91 Fillers, Diluents & Binders

49 Direct Compression

47 Coating Systems & Additives

35 Disintegrants & Superdisintegrants

30 Granulation

28 Lubricants & Glidants

25 Controlled & Modified Release

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