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Drug Product Composition: Metformin Hydrochloride

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$ API Ref.Price (USD/KG) : 4Xls

USFDA APPLICATION NUMBER - 21574 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N)
METFORMIN HYDROCHLORIDE1000mg

Inactive Ingredients

Ingredient Name
EPIC PHARMA, LLC
GLENMARK PHARMACEUTICALS INC., USA
NorthStar RxLLC
Solco Healthcare US, LLC.
American Health Packaging
AvKARE, Inc.
Bryant Ranch Prepack
Granules India Ltd
Lupin Pharmaceuticals, Inc.
Micro Labs Limited
Preferred Pharmaceuticals, Inc.
Lake Erie Medical DBA Quality Care Products LLC
Proficient Rx LP
REMEDYREPACK INC.
TWi Pharmaceuticals, Inc.
Depomed, Inc.
ACETONE(1364PS73AF)               
AMMONIA(5138Q19F1X)             
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)        
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)          
ANHYDROUS CITRIC ACID(XF417D3PSL)               
BUTYL ALCOHOL(8PJ61P6TS3)               
CANDELILLA WAX(WL0328HX19)               
CELLULOSE ACETATE(3J2P07GVB6)          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
CROSPOVIDONE (120 .MU.M)(68401960MK)              
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)            
CROSPOVIDONE(2S7830E561)             
CROSPOVIDONE(68401960MK)              
DIBUTYL SEBACATE(4W5IH7FLNY)          
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)               
FD&C BLUE NO. 2(L06K8R7DQK)              
FERROSOFERRIC OXIDE(XM0M87F357)       
GLYCERYL BEHENATE(R8WTH25YS2)               
GLYCERYL DIBEHENATE(R8WTH25YS2)              
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)               
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)            
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)              
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)               
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)           
HYPROMELLOSES(3NXW29V3WO)           
LECITHIN, SOYBEAN(1DI56QDM62)              
MAGNESIUM STEARATE(70097M6I30) 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)               
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)             
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)            
POLYETHYLENE GLYCOL 400(B697894SGQ)          
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)            
POLYETHYLENE GLYCOL(3WJQ0SDW1A)               
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)               
POLYSORBATE 80(6OZP39ZG8H)             
POLYVINYL ALCOHOL(532B59J990)              
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)            
POVIDONE K30(U725QWY32X)            
POVIDONE K90(RDH86HJV5Z)            
POVIDONE(FZ989GH94E)            
POVIDONE, UNSPECIFIED(FZ989GH94E)            
POVIDONES(FZ989GH94E)               
Propylene Glycol (6DC9Q167V3)               
PROPYLENE GLYCOL(6DC9Q167V3)          
SHELLAC(46N107B71O)            
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM BICARBONATE(8MDF5V39QO)               
SODIUM LAURYL SULFATE(368GB5141J)         
STARCH, CORN(O8232NY3SJ)              
TALC(7SEV7J4R1U)       
TITANIUM DIOXIDE(15FIX9V2JP)      
TRIACETIN(XHX3C3X673)            
TRIETHYL CITRATE(8Z96QXD6UM)            
VINYL ACETATE(L9MK238N77)               
XANTHAN GUM(TTV12P4NEE)