Atorvastatin

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ACTIVE PHARMA INGREDIENTS

207 API Suppliers, 65 USDMF, 42 CEP/COS, 20 JDMF, 34 EU WC, 90 KDMF, 26 NDC API, 74 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

61 Drugs in Development

61 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1919 FDF Dossiers, 198 FDA Orange Book, 1117 Europe, 101 Canada, 75 Australia, 77 South Africa, 351 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TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 80MG BASE,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

2 EUROAPI, 1 Minakem, 5 Evonik, 3 Rochem International Inc, 23 SPI Pharma, 18 DKSH, 1 Pharm-RX Chemical, 2 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Kewpie Corporation, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Pfanstiehl, 4 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 18 BASF, 1 BioSpectra, 1 CD Formulation, 12 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 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, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

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157 News #PharmaBuzz

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USFDA APPLICATION NUMBER - 21540 / DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG 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)

Setid D2d28679 A01b 4e63 90e2 D5c23b393c94 Applno 21540 Form Tablet Oral Dosage Eq 2 5mg Base Eq 40mg Base - Drug Product Composition: Atorvastatin

Atorvastatin

Atorvastatin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

207 API Suppliers

65 USDMF

42 CEP/COS

20 JDMF

34 EU WC

90 KDMF

26 NDC API

74 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

61 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1919 FDF Dossiers

198 FDA Orange Book

1117 Europe

101 Canada

75 Australia

77 South Africa

351 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

2 EUROAPI

1 Minakem

5 Evonik

3 Rochem International Inc

23 SPI Pharma

18 DKSH

1 Pharm-RX Chemical

2 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

2 Kewpie Corporation

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

3 Pfanstiehl

4 Kirsch Pharma

1 ACG Worldwide

7 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

18 BASF

1 BioSpectra

1 CD Formulation

12 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

1 Finar

10 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

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