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Drug Product Composition: (-)-Paroxetine

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$ API Ref.Price (USD/KG) : 456Xls

USFDA APPLICATION NUMBER - 20936 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8)
(PAROXETINE - UNII:41VRH5220H)
PAROXETINE25mg

Inactive Ingredients

Ingredient Name
Lupin Pharmaceuticals, Inc.
Apotex Corp
Mylan Pharmaceuticals Inc.
AvKARE, Inc.
Bryant Ranch Prepack
REMEDYREPACK INC.
GlaxoSmithKline Inc
ALUMINUM OXIDE(LMI26O6933)      
CASTOR OIL(D5340Y2I9G)      
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
D&C RED NO. 30(2S42T2808B)    
D&C YELLOW NO. 10(35SW5USQ3G)     
FD&C BLUE NO. 1(H3R47K3TBD)      
FD&C BLUE NO. 2 (L06K8R7DQK)      
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C YELLOW NO. 5(I753WB2F1M)      
FD&C YELLOW NO. 6 (H77VEI93A8)      
FD&C YELLOW NO. 6(H77VEI93A8)     
FERRIC OXIDE RED(1K09F3G675)      
FERRIC OXIDE YELLOW (EX438O2MRT)      
FERRIC OXIDE YELLOW (EX438O2MRT)      
FERRIC OXIDE YELLOW(EX438O2MRT)    
FERROSOFERRIC OXIDE(XM0M87F357)     
GLYCERYL DIBEHENATE(R8WTH25YS2)   
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)      
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)  
HYPROMELLOSES(3NXW29V3WO)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)      
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)   
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)(T967IEU43C)      
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
PIGMENT RED 48(07XHK4SAV6)      
POLYDEXTROSE(VH2XOU12IE)      
POLYETHYLENE GLYCOL 10000(H57W405143)    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)     
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)      
POLYSORBATE 80(6OZP39ZG8H)  
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)      
POVIDONE K30(U725QWY32X)  
POVIDONE(FZ989GH94E)      
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)      
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM ALGINATE(C269C4G2ZQ)      
SODIUM HYDROXIDE(55X04QC32I)      
SODIUM LAURYL SULFATE(368GB5141J)   
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)     
TRIETHYL CITRATE(8Z96QXD6UM)