Abiraterone Acetate

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 31 USDMF, 8 JDMF, 10 EU WC, 8 KDMF, 29 NDC API, 48 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

48 Drugs in Development

48 Drugs in Development

INTERMEDIATES

11 API Suppliers

11 API Suppliers

FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers, 25 FDA Orange Book, 20 Europe, 18 Canada, 2 Australia, 10 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG, TABLET;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 4 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 8 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 20 Kerry, 10 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 25 Direct Compression, 23 Coating Systems & Additives, 18 Granulation, 17 Lubricants & Glidants, 17 Disintegrants & Superdisintegrants, 14 Co-Processed Excipients, 13 Controlled & Modified Release, 12 Thickeners and Stabilizers, 8 Solubilizers, 6 Film Formers & Plasticizers, 5 Parenteral, 5 Taste Masking, 3 API Stability Enhancers, 3 Coloring Agents, 3 Topical, 3 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 160 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 14 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

16 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 202379 / DOSAGE - TABLET;ORAL - 250MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Abiraterone acetate(UNII: EM5OCB9YJ6) (Abiraterone - UNII:G819A456D0)	Abiraterone acetate	500mg \| 250mg

Inactive Ingredients

Ingredient Name	Amneal Pharmaceuticals NY LLC	AvKARE	CELLTRION USA, INC.	Hikma Pharmaceuticals USA Inc.	Rising Pharmaceuticals, Inc.	Glenmark Pharmaceuticals Inc., USA	Golden State Medical Supply, Inc.	Janssen Biotech, Inc.	Mylan Pharmaceuticals Inc.	Apotex Corp.	Major Pharmaceuticals
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
Hypromellose 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
Magnesium Stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
polyethylene glycol 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
povidone, unspecified(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium lauryl sulfate(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
Water(059QF0KO0R)

Drug Product Composition: Abiraterone Acetate