Dolutegravir

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 26 USDMF, 12 EU WC, 2 KDMF, 12 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

65 Drugs in Development

65 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 30 FDA Orange Book, 27 Europe, 5 Canada, 1 Australia, 63 South Africa, 2 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG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 Taste Masking, 12 Co-Processed Excipients, 11 Topical, 11 Parenteral, 5 Film Formers & Plasticizers, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 API Stability Enhancers

DIGITAL CONTENT

1 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

PATENTS & EXCLUSIVITIES

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

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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USFDA APPLICATION NUMBER - 204790 / DOSAGE - TABLET;ORAL - EQ 50MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOLUTEGRAVIR SODIUM(UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)	DOLUTEGRAVIR	50mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	REMEDYREPACK INC.
FERRIC OXIDE YELLOW(EX438O2MRT)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 30b06939 De33 48be 9dd3 Dc9741c96724 Applno 204790 Form Tablet Oral Dosage Eq 50mg Base - Drug Product Composition: Dolutegravir

Dolutegravir

Dolutegravir

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers

26 USDMF

12 EU WC

2 KDMF

12 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

65 Drugs in Development

INTERMEDIATES

40 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers

30 FDA Orange Book

27 Europe

5 Canada

1 Australia

63 South Africa

2 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

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