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Drug Product Composition: Dutasteride

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$ API Ref.Price (USD/KG) : 10,872Xls

USFDA APPLICATION NUMBER - 21319 / DOSAGE - CAPSULE;ORAL - 0.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE(UNII: O0J6XJN02I)
(DUTASTERIDE - UNII:O0J6XJN02I)
DUTASTERIDE0.5mg

Inactive Ingredients

Ingredient Name
Zydus Pharmaceuticals (USA) Inc.
A-S Medication Solutions
Apotex Corp.
Breckenridge Pharmaceutical, Inc.
Epic Pharma, LLC
Golden State Medical Supply
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Mylan Pharmaceuticals Inc.
NuCare Pharmaceuticals,Inc.
PuraCap Pharmaceutical LLC
Teva Pharmaceuticals USA Inc
Vensun Pharmaceuticals, Inc.
REMEDYREPACK INC.
Strides Pharma Science Limited
Actavis Pharma, Inc.
Avera McKennan Hospital
AvKARE, Inc.
AvPAK
Bryant Ranch Prepack
Camber Pharmaceuticals, Inc.
GlaxoSmithKline LLC
Golden State Medical Supply, Inc.
Lake Erie Medical & Surgcial Supply DBA Quality Care Products LLC
MARKSANS PHARMA LIMITED
Proficient Rx LP
West-Ward Pharmaceuticals Corp.
XLCare Pharmaceuticals, Inc.
ALCOHOL(3K9958V90M)                          
AMMONIA(5138Q19F1X)               
ANHYDROUS CITRIC ACID(XF417D3PSL)                         
BUTYL ALCOHOL(8PJ61P6TS3)                      
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CAPRIC ACID(4G9EDB6V73)                          
CAPRYLIC/CAPRIC ACID(DI775RT244)                         
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES(U72Q2I8C85)                          
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(U72Q2I8C85)           
DIMETHICONE(92RU3N3Y1O)                      
FD&C BLUE NO. 1(H3R47K3TBD)                          
FD&C RED NO. 40(WZB9127XOA)                          
FERRIC OXIDE RED(1K09F3G675)                 
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)             
GELATIN(2G86QN327L)       
GELATIN, UNSPECIFIED (2G86QN327L)                          
GELATIN, UNSPECIFIED(2G86QN327L)                    
GLYCERIN(PDC6A3C0OX) 
GLYCERYL CAPRYLATE/CAPRATE(G7515SW10N)                        
GLYCERYL CAPRYLOCAPRATE(U72Q2I8C85)                       
GLYCERYL MONO AND DICAPRYLOCAPRATE (U72Q2I8C85)                          
GLYCERYL MONO AND DICAPRYLOCAPRATE(U72Q2I8C85)                         
GLYCERYL MONOCAPRYLOCAPRATE(G7515SW10N)                          
GLYCINE(TE7660XO1C)                         
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                          
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                         
HYPROMELLOSES(3NXW29V3WO)                     
ISOPROPYL ALCOHOL(ND2M416302)                  
LECITHIN, SOYBEAN(1DI56QDM62)                      
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)               
METHYLPARABEN(A2I8C7HI9T)                          
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                          
POLYSORBATE 80(6OZP39ZG8H)                          
POLYVINYL ACETATE PHTHALATE(58QVG85GW3)                          
POTASSIUM HYDROXIDE(WZH3C48M4T)                          
PROPYLENE GLYCOL(6DC9Q167V3)      
PROPYLPARABEN(Z8IX2SC1OH)                          
SHELLAC(46N107B71O)              
SODIUM LAURYL SULFATE(368GB5141J)                          
SORBITOL(506T60A25R)                          
TALC(7SEV7J4R1U)                          
TITANIUM DIOXIDE(15FIX9V2JP)   
WATER(059QF0KO0R)