Abacavir Sulfate

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 12 USDMF, 10 CEP/COS, 1 JDMF, 11 EU WC, 3 KDMF, 14 NDC API, 15 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

66 FDF Dossiers, 34 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, 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20MG BASE/ML, TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 17 SPI Pharma, 2 Seqens, 5 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 13 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

64 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 35 Direct Compression, 33 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 24 Thickeners and Stabilizers, 23 Solubilizers, 21 Film Formers & Plasticizers, 20 Granulation, 20 Taste Masking, 18 Parenteral, 17 Co-Processed Excipients, 16 Chewable & Orodispersible Aids, 15 Topical, 14 Lubricants & Glidants, 8 Emulsifying Agents, 7 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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2 DATA COMPILATION #PharmaFlow, 23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug 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 USP, 2 Others

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USFDA APPLICATION NUMBER - 205551 / DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ABACAVIR SULFATE(UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)	ABACAVIR	600mg
DOLUTEGRAVIR SODIUM(UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)	DOLUTEGRAVIR	50mg
LAMIVUDINE(UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)	LAMIVUDINE	300mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Glaxo Operations UK Ltd
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Abacavir Sulfate