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(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide

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ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 27 USDMF, 12 EU WC, 2 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

154 Drugs in Development

154 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers, 30 FDA Orange Book, 27 Europe, 5 Canada, 4 Australia, 63 South Africa, 5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Kirsch Pharma, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 2 Ideal Cures, 2 Ingredion Pharma Solutions, 14 Kerry, 2 Keval Exports, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

56 Fillers, Diluents & Binders, 25 Direct Compression, 22 Granulation, 20 Coating Systems & Additives, 20 Disintegrants & Superdisintegrants, 18 Lubricants & Glidants, 16 Solubilizers, 15 Controlled & Modified Release, 15 Chewable & Orodispersible Aids, 15 Thickeners and Stabilizers, 12 Co-Processed Excipients, 12 Taste Masking, 11 Parenteral, 11 Topical, 5 Film Formers & Plasticizers, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 API Stability Enhancers, 2 Rheology Modifiers, 2 Emulsifying Agents

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2 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 128 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 7 Regulatory FDF Prices, 58 Annual Reports

MARKET PLACE

10 APIs, 8 FDF Dossiers

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36 US Patents, 5 US Exclusivities, 17 Health Canada Patents

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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
12/12/2025	Lupin Manufacturing Solutions	India	LUPIN MANUFACTURING SOLUTIONS LTD	31472	DOLUTEGRAVIR SODIUM (PROCESS A)	2017-04-13	Active	II	Complete	2017-06-01	2017-05-18
12/12/2025	Lupin Manufacturing Solutions	India	LUPIN MANUFACTURING SOLUTIONS LTD	31473	DOLUTEGRAVIR SODIUM ( PROCESS B)	2017-03-21	Active	II	Complete	2017-04-21	2017-03-29

(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide

(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers

27 USDMF

12 EU WC

2 KDMF

12 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

154 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers

30 FDA Orange Book

27 Europe

5 Canada

4 Australia

63 South Africa

5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 50MG BASE

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

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

15 SPI Pharma

3 DKSH

4 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

1 Kirsch Pharma

3 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

20 BASF

5 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

1 Finar

7 Gangwal Chemicals

2 Ideal Cures

2 Ingredion Pharma Solutions

14 Kerry

2 Keval Exports

12 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

13 Roquette

2 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 Silverline Chemicals

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

56 Fillers, Diluents & Binders

25 Direct Compression

22 Granulation

20 Coating Systems & Additives

20 Disintegrants & Superdisintegrants

18 Lubricants & Glidants

16 Solubilizers

TABLET;ORAL - EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons