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Atorvastatin

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ACTIVE PHARMA INGREDIENTS

152 API Suppliers, 69 USDMF, 43 CEP/COS, 22 JDMF, 30 EU WC, 86 KDMF, 26 NDC API, 76 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1547 FDF Dossiers, 187 FDA Orange Book, 790 Europe, 108 Canada, 85 Australia, 73 South Africa, 304 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 14 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Kewpie Corporation, 5 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 1 ACG Worldwide, 7 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 1 BioSpectra, 12 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 48 Direct Compression, 34 Disintegrants & Superdisintegrants, 31 Thickeners and Stabilizers, 31 Controlled & Modified Release, 24 Granulation, 23 Lubricants & Glidants, 23 Solubilizers, 22 Taste Masking, 21 Parenteral, 20 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 18 Film Formers & Plasticizers, 17 Topical, 11 Emulsifying Agents, 9 Rheology Modifiers, 9 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

14 DATA COMPILATION #PharmaFlow, 153 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 662 Finished Drug Prices, 20 Annual Reports

MARKET PLACE

55 APIs, 21 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

4 US Patents, 72 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 EDQM, 7 USP, 4 JP, 20 Others

ANALYTICAL

5 BioAnalytical Methods

5 BioAnalytical Methods

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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	Centrient Pharmaceuticals	Netherlands	CENTRIENT PHARMACEUTICALS NETHERLANDS BV	29520	ATORVASTATIN CALCIUM	2015-08-03	Active	II	Complete	2016-05-31	2015-08-20
28/10/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	18468	ATORVASTATIN CALCIUM (AMORPHOUS)	2005-06-29	Active	II	Complete	2013-02-27	2013-02-05

Atorvastatin

Atorvastatin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

152 API Suppliers

69 USDMF

43 CEP/COS

22 JDMF

30 EU WC

86 KDMF

26 NDC API

76 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1547 FDF Dossiers

187 FDA Orange Book

790 Europe

108 Canada

85 Australia

73 South Africa

304 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

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

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

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 20MG BASE

TABLET;ORAL - EQ 40MG BASE

TABLET;ORAL - EQ 80MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

22 SPI Pharma

2 Seqens

14 DKSH

3 Jai Radhe Sales

1 Pharm-RX Chemical

7 Faran Shimi Pharmaceutical

2 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

2 Kewpie Corporation

5 Nanjing Well Pharmaceutical

3 Pfanstiehl

1 ACG Worldwide

7 Actylis

2 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

18 BASF

1 BioSpectra

12 Corel Pharma Chem

7 DFE Pharma

1 Finar

10 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

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

TABLET;ORAL - EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons