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Drug Product Composition: Quetiapine Hemifumarate

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$ API Ref.Price (USD/KG) : 105Xls

USFDA APPLICATION NUMBER - 20639 / DOSAGE - TABLET;ORAL - EQ 200MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI)
QUETIAPINE FUMARATE200mg

Inactive Ingredients

Ingredient Name
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
Cardinal Health
Avera McKennan Hospital
Clinical Solutions Wholesale
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
Breckenridge Pharmaceutical, Inc
American Health Packaging
Bryant Ranch Prepack
Major Pharmaceuticals
Safecor Health, LLC
TYA Pharmaceuticals
Accord Healthcare Inc.
Citron Pharma LLC
Clinical Solutions Wholesale, LLC
Contract Pharmacy Services-PA
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Direct_Rx
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
NCS HealthCare of KY, LLC dba Vangard Labs
Northstar RxLLC
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
Physicians Total Care, Inc.
Quality Care Products, LLC
TORRENT PHARMACEUTICALS LIMITED
A-S Medication Solutions
Apotex Corp.
Golden State Medical Supply, Inc.
Solco Healthcare US, LLC
BluePoint Laboratories
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
RPK Pharmaceuticals, Inc.
Sandoz Inc
REMEDYREPACK INC.
TORRENT PHARMACEUTI
TORRENT PHARMACEUTICALS LIMITE
ALUMINUM OXIDE(LMI26O6933)                                      
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)                                       
ANHYDROUS CITRIC ACID(XF417D3PSL)                                    
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                                       
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)                                
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)              
colloidal silicon dioxide(ETJ7Z6XBU4)                                       
CROSCARMELLOSE SODIUM(M28OL1HH48)                                    
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                       
CROSPOVIDONE(2S7830E561)                                      
CROSPOVIDONE(68401960MK)                                      
D&C YELLOW NO. 10(35SW5USQ3G)                                       
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)           
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                                       
ETHYLCELLULOSES(7Z8S9VYZ4B)                                     
FD&C YELLOW NO. 6(H77VEI93A8)                                     
FERRIC OXIDE RED(1K09F3G675)                   
FERRIC OXIDE YELLOW(EX438O2MRT)          
FERROSOFERRIC OXIDE(XM0M87F357)                                    
FUMARIC ACID(88XHZ13131)                                   
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)                                       
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                       
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                       
Hydroxypropyl Cellulose (Type L)(UKE75GEA7F)                                     
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                                    
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                                      
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                     
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)                                      
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                
HYPROMELLOSE(3NXW29V3WO)                                       
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                                 
HYPROMELLOSES(3NXW29V3WO)                                
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
LACTOSE(J2B2A4N98G)                                       
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(3WJQ0SDW1A)                                      
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                               
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                 
POLYSORBATE 80(6OZP39ZG8H)                                    
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                                       
POVIDONE K12(333AG72FWJ)                                       
POVIDONE K25(K0KQV10C35)                                    
POVIDONE K26/28(H7AGY1OJO8)                                      
POVIDONE K27(H7AGY1OJO8)                                      
POVIDONE K29/32(390RMW2PEQ)                                       
POVIDONE K30(U725QWY32X)                          
POVIDONE(FZ989GH94E)                           
POVIDONE, UNSPECIFIED(FZ989GH94E)                             
POVIDONES(FZ989GH94E)                                  
PROPYLENE GLYCOL(6DC9Q167V3)                                       
SHELLAC(46N107B71O)                                       
SILICON DIOXIDE(ETJ7Z6XBU4)                      
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)      
STARCH, CORN(O8232NY3SJ)                                    
TALC(7SEV7J4R1U)                                
TITANIUM DIOXIDE(15FIX9V2JP)     
TRIACETIN(XHX3C3X673)                                    
WATER(059QF0KO0R)