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    Drug Product Composition: Darunavir

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    Darunavir

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

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    GLOBAL SALES INFORMATION

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    PharmaCompass
    $ API Ref.Price (USD/KG) : 952Xls

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    USFDA APPLICATION NUMBER - 21976 / DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    darunavir ethanolate(UNII: 33O78XF0BW)
    (darunavir - UNII:YO603Y8113)     		darunavir600mg

    Inactive Ingredients

    Ingredient Name
    A-S Medication Solutions
    Avera McKennan Hospital
    REMEDYREPACK INC.
    cellulose, microcrystalline(OP1R32D61U)  
    CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
    crospovidone(68401960MK)  
    FD&C Yellow No. 6(H77VEI93A8) 
    FERRIC OXIDE RED(1K09F3G675)
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
    MAGNESIUM STEARATE(70097M6I30)
    microcrystalline cellulose(OP1R32D61U)
    POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
    polyvinyl alcohol(532B59J990)  
    polyvinyl alcohol, unspecified(532B59J990)
    silicon dioxide(ETJ7Z6XBU4)
    TALC(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)