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Efavirenz

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 28 USDMF, 13 EU WC, 2 KDMF, 22 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

196 FDF Dossiers, 59 FDA Orange Book, 40 Europe, 11 Canada, 67 South Africa, 19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG;300MG;300MG, CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG, TABLET;ORAL - 600MG;200MG;300MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 8 DKSH, 4 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Coating Systems & Additives, 48 Fillers, Diluents & Binders, 29 Controlled & Modified Release, 25 Disintegrants & Superdisintegrants, 22 Direct Compression, 21 Thickeners and Stabilizers, 17 Lubricants & Glidants, 17 Granulation, 11 Co-Processed Excipients, 10 Topical, 9 Empty Capsules, 8 Film Formers & Plasticizers, 6 Taste Masking, 5 Parenteral, 5 API Stability Enhancers, 5 Coloring Agents, 5 Solubilizers, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 55 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 24 Finished Drug Prices, 15 Annual Reports

MARKET PLACE

8 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 5 Others

ANALYTICAL

1 BioAnalytical Methods

1 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
28/11/2024	Acebright India Pharma Private Limited	India	CDYMAX INDIA PHARMA PRIVATE LTD	24847	EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)]	2011-04-08	Active	II	Complete	2013-12-17	2013-05-08
28/11/2024	Arene Lifesciences	India	ARENE LIFE SCIENCES PRIVATE LTD	33854	EFAVIRENZ USP	2019-06-12	Active	II	N/A

Efavirenz

Efavirenz

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers

28 USDMF

13 EU WC

2 KDMF

22 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

196 FDF Dossiers

59 FDA Orange Book

40 Europe

11 Canada

67 South Africa

19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG;300MG;300MG

CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 600MG

TABLET;ORAL - 600MG;200MG;300MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

2 Seqens

8 DKSH

4 Faran Shimi Pharmaceutical

10 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

4 ACG Worldwide

3 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

10 Corel Pharma Chem

6 DFE Pharma

1 Finar

7 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

31 Kerry

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

12 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

12 Sigachi Industries

2 The Dow Chemical Company

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Coating Systems & Additives

48 Fillers, Diluents & Binders

29 Controlled & Modified Release

25 Disintegrants & Superdisintegrants

22 Direct Compression

21 Thickeners and Stabilizers

17 Lubricants & Glidants

17 Granulation

11 Co-Processed Excipients

10 Topical

9 Empty Capsules

CAPSULE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons