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Drug Product Composition: Pregabalin

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$ API Ref.Price (USD/KG) : 110Xls

USFDA APPLICATION NUMBER - 21446 / DOSAGE - CAPSULE;ORAL - 50MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M)
PREGABALIN75mg

Inactive Ingredients

Ingredient Name
Direct_Rx
Teva Pharmaceuticals USA, Inc.
A-S Medication Solutions
Cipla USA Inc.
Golden State Medical Supply Inc.
A-S Medication Solutions LLC
Ascend Laboratories, LLC
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Proficient Rx LP
Quality Care Products, LLC
REMEDYREPACK INC.
Tris Pharma Inc
Unit Dose Services
U.S. Pharmaceuticals
ALCOHOL(3K9958V90M)                
AMMONIA(5138Q19F1X)                
BUTYL ALCOHOL(8PJ61P6TS3)                
D&C YELLOW NO. 10(35SW5USQ3G)                
FD&C BLUE NO. 1(H3R47K3TBD)             
FD&C RED NO. 40(WZB9127XOA)             
FD&C YELLOW NO. 6(H77VEI93A8)            
FERRIC OXIDE RED(1K09F3G675)    
FERRIC OXIDE YELLOW(EX438O2MRT)             
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)            
GELATIN, UNSPECIFIED(2G86QN327L)    
ISOPROPYL ALCOHOL(ND2M416302)                
LACTOSE MONOHYDRATE(EWQ57Q8I5X)        
MANNITOL(3OWL53L36A)                
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)                
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM LAURYL SULFATE(368GB5141J)  
STARCH, CORN(O8232NY3SJ) 
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)