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Stavudine

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 14 USDMF, 1 CEP/COS, 2 EU WC, 4 NDC API, 1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

99 FDF Dossiers, 47 FDA Orange Book, 18 Europe, 21 South Africa, 13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 14 SPI Pharma, 10 DKSH, 3 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 2 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 9 BASF, 4 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 12 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 13 Microlex e.U, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 15 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders, 25 Thickeners and Stabilizers, 22 Direct Compression, 18 Disintegrants & Superdisintegrants, 17 Taste Masking, 15 Granulation, 14 Coating Systems & Additives, 12 Lubricants & Glidants, 12 Chewable & Orodispersible Aids, 12 Co-Processed Excipients, 8 Empty Capsules, 6 Solubilizers, 6 Parenteral, 6 Film Formers & Plasticizers, 5 Controlled & Modified Release, 5 Rheology Modifiers, 4 Topical, 3 Coloring Agents, 2 Emulsifying Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 News #PharmaBuzz

3 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 Regulatory FDF Prices

9 Regulatory FDF Prices

MARKET PLACE

1 APIs

1 APIs

PATENTS & EXCLUSIVITIES

9 Health Canada Patents

9 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 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
25/04/2025	Arch Pharmalabs	India	VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)	21902	STAVUDINE USP	2008-08-21	Inactive	II	N/A
25/04/2025	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	17968	STAVUDINE USP	2004-12-30	Active	II	N/A

Stavudine

Stavudine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

15 API Suppliers

14 USDMF

1 CEP/COS

2 EU WC

4 NDC API

1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

99 FDF Dossiers

47 FDA Orange Book

18 Europe

21 South Africa

13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SOLUTION;ORAL - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc

14 SPI Pharma

10 DKSH

3 Faran Shimi Pharmaceutical

4 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

2 Actylis

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

9 BASF

4 DFE Pharma

1 Finar

4 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

12 Kerry

1 Kima Chemical

3 Lonza Capsugel

13 Microlex e.U

2 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qualicaps

15 Roquette

1 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

9 Sigachi Industries

3 Silverline Chemicals

1 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders

25 Thickeners and Stabilizers

22 Direct Compression

18 Disintegrants & Superdisintegrants

17 Taste Masking

15 Granulation

14 Coating Systems & Additives

12 Lubricants & Glidants

12 Chewable & Orodispersible Aids

12 Co-Processed Excipients

8 Empty Capsules

6 Solubilizers

6 Parenteral

6 Film Formers & Plasticizers

5 Controlled & Modified Release

5 Rheology Modifiers

4 Topical

3 Coloring Agents

2 Emulsifying Agents

CAPSULE;ORAL - 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FOR SOLUTION;ORAL - 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons