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    Drug Product Composition: Choline Fenofibrate

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    Choline Fenofibrate

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    $ API Ref.Price (USD/KG) : 130Xls

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    USFDA APPLICATION NUMBER - 22224 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 135MG FENOFIBRIC ACID

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FENOFIBRIC ACID(UNII: BGF9MN2HU1)
    (FENOFIBRIC ACID - UNII:BGF9MN2HU1)     		FENOFIBRIC ACID45mg | 135 mg | 45mg | 135 mg

    Inactive Ingredients

    Ingredient Name
    Actavis Pharma, Inc.
    Graviti Pharmaceuticals Private Limited
    Laurus Labs Limited
    Leading Pharma, LLC
    Mylan Institutional Inc.
    Mylan Pharmaceuticals Inc.
    Golden State Medical Supply
    Par Pharmaceutical, Inc.
    A-S Medication Solutions
    Lupin Pharmaceuticals, Inc.
    Micro Labs Limited
    Alembic Pharmaceuticals Inc.
    AMMONIA(5138Q19F1X)      
    AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)           
    AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)           
    D&C YELLOW NO. 10(35SW5USQ3G)          
    DIBUTYL SEBACATE(4W5IH7FLNY)          
    ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)           
    ETHYLCELLULOSES(7Z8S9VYZ4B)           
    FD&C BLUE NO. 1(H3R47K3TBD)    
    FD&C BLUE NO. 2(L06K8R7DQK)       
    FD&C RED NO. 3(PN2ZH5LOQY)        
    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)          
    HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)           
    HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)         
    HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)           
    HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)           
    HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)           
    HYDROXYPROPYL CELLULOSE (TYPE M)(U3JF91U133)          
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)           
    HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)        
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
    HYPROMELLOSES(3NXW29V3WO)         
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)        
    MAGNESIUM STEARATE(70097M6I30)        
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)     
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)          
    METHACRYLIC ACID(1CS02G8656)           
    METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)           
    MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK)           
    POLYSORBATE 80(6OZP39ZG8H)       
    POTASSIUM HYDROXIDE(WZH3C48M4T)     
    POVIDONE K30(U725QWY32X)       
    POVIDONE K90(RDH86HJV5Z)          
    POVIDONE, UNSPECIFIED(FZ989GH94E)           
    POVIDONES(FZ989GH94E)           
    PROPYLENE GLYCOL(6DC9Q167V3) 
    SHELLAC(46N107B71O) 
    SILICON DIOXIDE(ETJ7Z6XBU4)   
    SODIUM LAURYL SULFATE(368GB5141J)    
    SODIUM STEARYL FUMARATE(7CV7WJK4UI)   
    STARCH, CORN(O8232NY3SJ)           
    STEARIC ACID(4ELV7Z65AP)          
    SUCROSE(C151H8M554)           
    TALC(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)
    TRIETHYL CITRATE(8Z96QXD6UM)
    WATER(059QF0KO0R)