Atorvastatin

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150 API Suppliers, 71 USDMF, 42 CEP/COS, 22 JDMF, 30 EU WC, 87 KDMF, 22 NDC API, 74 Listed Suppliers, $ API Reference Price

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12 Drugs in Development

12 Drugs in Development

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18 API Suppliers

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

1541 FDF Dossiers, 187 FDA Orange Book, 790 Europe, 108 Canada, 85 Australia, 73 South Africa, 298 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TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 80MG BASE,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, 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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USFDA APPLICATION NUMBER - 200153 / DOSAGE - TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)	ATORVASTATIN	80mg \| 40mg \| 20mg \| 10mg
EZETIMIBE(UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)	EZETIMIBE	10mg \| 10mg \| 10mg \| 10mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.
ANHYDROUS LACTOSE(3SY5LH9PMK)
CARNAUBA WAX(R12CBM0EIZ)
CROSCARMELLOSE SODIUM(M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE K29/32(390RMW2PEQ)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM LAURYL SULFATE(368GB5141J)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Atorvastatin

Atorvastatin

Atorvastatin

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ACTIVE PHARMA INGREDIENTS

150 API Suppliers

71 USDMF

42 CEP/COS

22 JDMF

30 EU WC

87 KDMF

22 NDC API

74 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

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API Reference Price

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FDF Imports

INTERMEDIATES

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

1541 FDF Dossiers

187 FDA Orange Book

790 Europe

108 Canada

85 Australia

73 South Africa

298 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

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

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