Dolutegravir Sodium

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ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 27 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG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 Co-Processed Excipients, 12 Taste Masking, 11 Parenteral, 11 Topical, 5 Film Formers & Plasticizers, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 Emulsifying Agents, 2 API Stability Enhancers, 2 Rheology Modifiers

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 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 25mg Base - Drug Product Composition: Dolutegravir Sodium