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ACTIVE PHARMA INGREDIENTS

77 API Suppliers, 29 USDMF, 11 JDMF, 17 EU WC, 63 KDMF, 18 NDC API, 50 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

34 Intermediate Suppliers

34 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

595 FDF Dossiers, 66 FDA Orange Book, 356 Europe, 22 Canada, 23 Australia, 27 South Africa, 101 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TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 6 SPI Pharma, 4 DKSH, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pramukh Pharmachem, 1 ACG Worldwide, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 41 Disintegrants & Superdisintegrants, 29 Direct Compression, 27 Granulation, 24 Controlled & Modified Release, 22 Lubricants & Glidants, 17 Thickeners and Stabilizers, 11 Chewable & Orodispersible Aids, 11 Co-Processed Excipients, 9 Taste Masking, 9 Solubilizers, 9 Film Formers & Plasticizers, 6 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 4 Parenteral, 3 Rheology Modifiers, 2 Topical, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

111 NEWS #PharmaBuzz

111 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 329 Finished Drug Prices, 38 Annual Reports

MARKET PLACE

20 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 3 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

ANALYTICAL

6 BioAnalytical Methods

6 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
28/01/2025	Neuland Laboratories	India	NEULAND LABORATORIES LTD	25543	EZETIMIBE USP (FORM-X)	2011-11-30	Active	II	Complete	2018-08-14	2018-07-05
28/01/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	20039	EZETIMIBE	2006-12-13	Active	II	Complete	2013-04-17	2013-04-04

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

77 API Suppliers

29 USDMF

11 JDMF

17 EU WC

63 KDMF

18 NDC API

50 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

20 Drugs in Development

INTERMEDIATES

34 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

595 FDF Dossiers

66 FDA Orange Book

356 Europe

22 Canada

23 Australia

27 South Africa

101 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 - 10MG

TABLET;ORAL - 10MG;10MG

TABLET;ORAL - 10MG;20MG

TABLET;ORAL - 10MG;40MG

TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem

6 SPI Pharma

4 DKSH

6 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pramukh Pharmachem

1 ACG Worldwide

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

19 BASF

10 Corel Pharma Chem

7 DFE Pharma

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 NEWEDGE Overseas

3 Novo Excipients

5 Pharmatrans-Sanaq

6 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

12 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders

47 Coating Systems & Additives

41 Disintegrants & Superdisintegrants

29 Direct Compression

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