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Drug Product Composition: Quetiapine Hemifumarate

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$ API Ref.Price (USD/KG) : 121Xls

USFDA APPLICATION NUMBER - 22047 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI)
QUETIAPINE150mg | 50mg | 300mg | 200mg

Inactive Ingredients

Ingredient Name
Tris Pharma Inc.
Accord Healthcare Inc.
BluePoint Laboratories
Lupin Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical Inc.
REMEDYREPACK INC.
TruPharma, LLC
Solco Healthcare U.S., LLC
Carilion Materials Management
ACI Healthcare USA, Inc.
AstraZeneca Pharmaceuticals LP
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
Major Pharmaceuticals
ScieGen Pharmaceuticals, Inc
A-S Medication Solutions
Direct_Rx
Bluepoint Laboratories
Akron Pharma Inc
ANHYDROUS LACTOSE(3SY5LH9PMK)                   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)             
D&C YELLOW NO. 10(35SW5USQ3G)                  
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)                   
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                   
ETHYLCELLULOSES(7Z8S9VYZ4B)                  
FD&C BLUE NO. 2(L06K8R7DQK)                   
FD&C RED NO. 40(WZB9127XOA)                  
FD&C YELLOW NO. 5(I753WB2F1M)                   
FD&C YELLOW NO. 6(H77VEI93A8)                 
FERRIC OXIDE RED(1K09F3G675)    
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)                   
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45)                   
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)              
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)                 
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T)              
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                   
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)                  
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                  
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
HYPROMELLOSES(3NXW29V3WO)                 
LACTOSE MONOHYDRATE(EWQ57Q8I5X) 
LECITHIN, SOYBEAN(1DI56QDM62)                  
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
POLYDEXTROSE(VH2XOU12IE)                  
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                  
POLYETHYLENE GLYCOL 400(B697894SGQ)        
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                  
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)               
POLYVINYL ALCOHOL(532B59J990)                  
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                
POVIDONE K30(U725QWY32X)                
POVIDONE(FZ989GH94E)                   
PROPYLENE GLYCOL(6DC9Q167V3)                   
SILICON DIOXIDE(ETJ7Z6XBU4)              
SODIUM CHLORIDE(451W47IQ8X)                
SODIUM CITRATE(1Q73Q2JULR)                  
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)                
TALC(7SEV7J4R1U)            
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)                  
TRISODIUM CITRATE DIHYDRATE(B22547B95K)        
WATER(059QF0KO0R)