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Drug Product Composition: Mycophenolate Mofetil

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$ API Ref.Price (USD/KG) : 177Xls

USFDA APPLICATION NUMBER - 50722 / DOSAGE - CAPSULE;ORAL - 250MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mycophenolate Mofetil(UNII: 9242ECW6R0)
(mycophenolic acid - UNII:HU9DX48N0T)
Mycophenolate Mofetil250mg

Inactive Ingredients

Ingredient Name
Advagen Pharma Limited
American Health Packaging
Apotex Corp
CONCORD BIOTECH LIMITED
Genentech, Inc.
Lupin Pharmaceuticals, Inc.
Avet Pharmaceuticals Inc
Greenstone LLC
JUBILANT CADISTA PHARMACEUTICALS, INC.
Zydus Pharmaceuticals (USA) Inc.
Cardinal Health
Lake Erie Medical DBA Quality Care Products LLC
ALCOHOL(3K9958V90M)      
AMMONIA(5138Q19F1X)      
ANHYDROUS CITRIC ACID(XF417D3PSL)           
ASPARTAME(Z0H242BBR1)           
BUTYL ALCOHOL(8PJ61P6TS3)       
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
Croscarmellose Sodium(M28OL1HH48)
FD&C BLUE NO. 1(H3R47K3TBD)          
FD&C BLUE NO. 2(L06K8R7DQK)    
FD&C RED NO. 3(PN2ZH5LOQY)         
FD&C RED NO. 40(WZB9127XOA)           
ferric oxide red(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERRIC OXIDE(1K09F3G675)           
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)          
HYDROCHLORIC ACID(QTT17582CB)           
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)         
Hydroxypropyl Cellulose (type H)(RFW2ET671P)         
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)           
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)          
HYPROMELLOSE(3NXW29V3WO)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)           
HYPROMELLOSES(3NXW29V3WO)        
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)          
ISOPROPYL ALCOHOL(ND2M416302)       
LECITHIN, SOYBEAN(1DI56QDM62)           
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)           
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)           
Polyethylene Glycol 1000(U076Q6Q621)           
POLYETHYLENE GLYCOL 400(B697894SGQ)        
POLYETHYLENE GLYCOL(3WJQ0SDW1A)          
POLYSORBATE 80(6OZP39ZG8H)           
POTASSIUM HYDROXIDE(WZH3C48M4T)      
POVIDONE K30(U725QWY32X)          
Povidone K90(RDH86HJV5Z)   
POVIDONE(FZ989GH94E)           
PROPYLENE GLYCOL(6DC9Q167V3)      
SHELLAC(46N107B71O)     
SILICON DIOXIDE(ETJ7Z6XBU4)      
SODIUM HYDROXIDE(55X04QC32I)           
Sodium Lauryl Sulfate(368GB5141J)
SORBITOL(506T60A25R)           
STARCH, CORN(O8232NY3SJ)       
STARCH, PREGELATINIZED CORN(O8232NY3SJ)           
TALC(7SEV7J4R1U)      
TITANIUM DIOXIDE(15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)           
WATER(059QF0KO0R)      
XANTHAN GUM(TTV12P4NEE)