Eltrombopag Olamine

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 17 USDMF, 5 EU WC, 12 NDC API, 30 Listed Suppliers, $ API Reference Price

INTERMEDIATES

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17 API Suppliers

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 25 FDA Orange Book, 10 Europe, 4 Canada, 16 Australia, 2 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 12.5MG ACID, TABLET;ORAL - EQ 25MG ACID, TABLET;ORAL - EQ 50MG ACID, TABLET;ORAL - EQ 75MG ACID

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3 Rochem International Inc, 13 SPI Pharma, 5 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 3 DFE Pharma, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 14 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

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51 Coating Systems & Additives, 49 Fillers, Diluents & Binders, 29 Direct Compression, 27 Controlled & Modified Release, 20 Thickeners and Stabilizers, 18 Disintegrants & Superdisintegrants, 18 Solubilizers, 16 Granulation, 14 Taste Masking, 13 Parenteral, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 11 Film Formers & Plasticizers, 8 Topical, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

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PATENTS & EXCLUSIVITIES

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USFDA APPLICATION NUMBER - 22291 / DOSAGE - TABLET;ORAL - EQ 12.5MG ACID

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG) (ELTROMBOPAG - UNII:S56D65XJ9G)	ELTROMBOPAG	25mg \| 75mg \| 12.5mg \| 100mg \| 25mg \| 50mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
POVIDONES(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SUCRALOSE(96K6UQ3ZD4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Eltrombopag Olamine