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Drug Product Composition: Abiraterone

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$ API Ref.Price (USD/KG) : 1,973Xls

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

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Abiraterone acetate(UNII: EM5OCB9YJ6)
(Abiraterone - UNII:G819A456D0)
Abiraterone acetate500mg | 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)