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Drug Product Composition: Paliperidone

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$ API Ref.Price (USD/KG) : 42,440Xls

USFDA APPLICATION NUMBER - 21999 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 6MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone(UNII: 838F01T721)
(paliperidone - UNII:838F01T721)
paliperidone3mg

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
Major Pharmaceuticals
Tris Pharma Inc
Avera McKennan Hospital
Inventia Healthcare Limited
Lupin Pharmaceuticals, Inc.
REMEDYREPACK INC.
Ascent Pharmaceuticals, Inc.
Ammonia(5138Q19F1X)     
ANHYDROUS LACTOSE(3SY5LH9PMK)       
BUTYL ALCOHOL(8PJ61P6TS3)      
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(F68VH75CJC)       
CARNAUBA WAX(R12CBM0EIZ)      
CELLULOSE ACETATE(3J2P07GVB6)  
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
DIBUTYL SEBACATE(4W5IH7FLNY)       
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)       
ETHYLCELLULOSES(7Z8S9VYZ4B)       
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)       
FD&C RED NO. 40(WZB9127XOA)      
FERRIC OXIDE RED(1K09F3G675)  
FERRIC OXIDE YELLOW(EX438O2MRT)  
ferrosoferric oxide(XM0M87F357) 
FUMARIC ACID(88XHZ13131)       
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)       
HYDROXYPROPYL CELLULOSE (20000 WAMW)(KZQ570MOA5)       
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT)       
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)       
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)       
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
HYPROMELLOSES(3NXW29V3WO)   
Isopropyl alcohol(ND2M416302)       
LACTOSE MONOHYDRATE(EWQ57Q8I5X) 
MAGNESIUM STEARATE(70097M6I30)    
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)       
POLYDEXTROSE(VH2XOU12IE)       
POLYETHYLENE GLYCOL 100000(V46Y6OJ5QB)       
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)      
POLYETHYLENE GLYCOL 400(B697894SGQ)       
POLYETHYLENE GLYCOL 7000000(G3MS6M810Y)       
POLYETHYLENE GLYCOL(3WJQ0SDW1A)       
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)  
polyethylene glycols(3WJQ0SDW1A)       
POLYETHYLENE OXIDE 200000(11628IH70O)     
POLYETHYLENE OXIDE 7000000(G3MS6M810Y)      
POLYSORBATE 80(6OZP39ZG8H)       
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)       
Povidone K30(U725QWY32X)      
POVIDONE(FZ989GH94E)     
POVIDONE, UNSPECIFIED(FZ989GH94E)      
povidones(FZ989GH94E)       
PROPYLENE GLYCOL(6DC9Q167V3) 
Shellac(46N107B71O)    
SILICON DIOXIDE(ETJ7Z6XBU4)     
SODIUM CHLORIDE(451W47IQ8X)  
STEARIC ACID(4ELV7Z65AP)  
TALC(7SEV7J4R1U)    
titanium dioxide(15FIX9V2JP)
triacetin(XHX3C3X673)    
TRIETHYL CITRATE(8Z96QXD6UM)