Lipitor

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ACTIVE PHARMA INGREDIENTS

154 API Suppliers, 69 USDMF, 43 CEP/COS, 22 JDMF, 30 EU WC, 86 KDMF, 26 NDC API, 77 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1554 FDF Dossiers, 187 FDA Orange Book, 790 Europe, 108 Canada, 85 Australia, 73 South Africa, 311 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TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 80MG BASE,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, 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

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

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

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ANALYTICAL

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5 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21540 / DOSAGE - TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10mg \| 10mg \| 10mg \| 10mg \| 5mg \| 5mg \| 5mg \| 5mg \| 2.5mg \| 2.5mg \| 2.5mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	80mg \| 40mg \| 20mg \| 10mg \| 80mg \| 40mg \| 20mg \| 10mg \| 40mg \| 20mg \| 10mg

Inactive Ingredients

Ingredient Name	Mylan Pharmaceuticals Inc.	Pfizer Laboratories Div Pfizer Inc	Ranbaxy Pharmaceuticals Inc	Zydus Pharmaceuticals (USA) Inc.	Dr. Reddy's Laboratories Inc
ARGININE(94ZLA3W45F)
CALCIUM CARBONATE(H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
Crospovidone(2S7830E561)
FD&C BLUE NO. 2(L06K8R7DQK)
Hydrogenated Soybean Lecithin(H1109Z9J4N)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
Hydroxypropyl Cellulose, Unspecified(9XZ8H6N6OH)
HYPROMELLOSES(3NXW29V3WO)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3000(SA1B764746)
polyethylene glycol 3350(G2M7P15E5P)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
Polyvinyl Alcohol, Unspecified(532B59J990)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium bicarbonate(8MDF5V39QO)
SODIUM CARBONATE(45P3261C7T)
sodium lauryl sulfate(368GB5141J)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Lipitor

Lipitor

Lipitor

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

154 API Suppliers

69 USDMF

43 CEP/COS

22 JDMF

30 EU WC

86 KDMF

26 NDC API

77 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1554 FDF Dossiers

187 FDA Orange Book

790 Europe

108 Canada

85 Australia

73 South Africa

311 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

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