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ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 12 USDMF, 10 CEP/COS, 1 JDMF, 11 EU WC, 3 KDMF, 15 NDC API, 17 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

67 FDF Dossiers, 35 FDA Orange Book, 8 Europe, 11 Canada, 10 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG, TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 20MG BASE/ML, TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 18 SPI Pharma, 7 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 1 Clariant, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 32 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 27 Direct Compression, 25 Thickeners and Stabilizers, 24 Solubilizers, 21 Film Formers & Plasticizers, 21 Taste Masking, 20 Granulation, 17 Chewable & Orodispersible Aids, 16 Parenteral, 15 Topical, 14 Co-Processed Excipients, 13 Lubricants & Glidants, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 23 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Regulatory FDF Prices, 5 Annual Reports

MARKET PLACE

1 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 US Patents, 4 US Exclusivities, 8 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	39537	ABACAVIR SULFATE USP (PROCESS II)	2024-03-29	Active	II	Complete	2024-04-29	2024-02-23
28/03/2025	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	18256	ABACAVIR SULFATE USP	2005-03-24	Active	II	Complete	2013-09-04	2013-08-21

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers

12 USDMF

10 CEP/COS

1 JDMF

11 EU WC

3 KDMF

15 NDC API

17 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

67 FDF Dossiers

35 FDA Orange Book

8 Europe

11 Canada

10 South Africa

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

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

SOLUTION;ORAL - EQ 20MG BASE/ML

TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc

18 SPI Pharma

7 DKSH

5 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

8 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

22 BASF

1 Clariant

10 Corel Pharma Chem

4 DFE Pharma

2 Finar

11 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

19 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

29 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders

53 Coating Systems & Additives

32 Controlled & Modified Release

32 Disintegrants & Superdisintegrants

27 Direct Compression

25 Thickeners and Stabilizers

24 Solubilizers

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

TABLET;ORAL - EQ 600MG BASE;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons