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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Biocon to the U.S. FDA. Original Data : FDA Website

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    01 ANIDULAFUNGIN (DRUG SUBSTANCE INTERMEDIATE) (1)

    02 APIXABAN (1)

    03 ATORVASTATIN CALCIUM (USP) CRYSTALLINE (1)

    04 ATORVASTATIN CALCIUM AMORPHOUS (1)

    05 ATORVASTATIN MAGNESIUM (1)

    06 BRINZOLAMIDE USP (STERILIZED) (1)

    07 CABOZANTINIB-(S)-MALATE (1)

    08 COMPACTIN (1)

    09 DABIGATRAN ETEXILATE MESYLATE (1)

    10 DAPAGLIFLOZIN (1)

    11 DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (1)

    12 DASATINIB MONOHYDRATE (1)

    13 DEFERASIROX (1)

    14 DRUG SUBSTANCE INTERMEDIATE IMMUNOMYCIN (1)

    15 EMPAGLIFLOZIN (1)

    16 EVEROLIMUS (1)

    17 EVEROLIMUS (2% BHT) (1)

    18 EVEROLIMUS (WITH 0.2% BHT) (1)

    19 EVEROLIMUS PREMIX 2% (1)

    20 FINGOLIMOD HYDROCHLORIDE (1)

    21 FLUVASTATIN SODIUM (1)

    22 FLUVASTATIN SODIUM (1)

    23 FLUVASTATIN SODIUM AMORPHOUS (1)

    24 HUMAN INSULIN DRUG SUBSTANCE (rDNA ORIGIN) (1)

    25 HUMAN INSULIN-BULK (RDNA ORIGIN) (1)

    26 HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) (1)

    27 HUMAN INSULIN-BULK (rDNA ORIGIN) - (ANIMAL ORIGIN FREE) (1)

    28 HYDROXY ECHINOCANDIN (1)

    29 INSULIN GLARGINE (RDNA ORIGIN) (1)

    30 LENALIDOMIDE (1)

    31 LINAGLIPTIN (1)

    32 LIRAGLUTIDE (1)

    33 LOVASTATIN TECHNICAL(SFP) (1)

    34 LOVASTATIN USP (1)

    35 MICAFUNGIN SODIUM (1)

    36 MIRABEGRON (1)

    37 MYCOPHENOLATE MOFETIL (1)

    38 MYCOPHENOLATE SODIUM (1)

    39 MYCOPHENOLIC ACID (1)

    40 ORLISTAT (1)

    41 ORLISTAT USP (1)

    42 PAPAIN (1)

    43 PIMECROLIMUS (1)

    44 PIOGLITAZONE HYDROCHLORIDE USP (2)

    45 POSACONAZOLE (2)

    46 PRAVASTATIN SODIUM (1)

    47 PRAVASTATIN SODIUM USP (1)

    48 REPAGLINIDE (1)

    49 RIVAROXABAN USP (1)

    50 ROSIGLITAZONE MALEATE DRUG SUBSTANCE (1)

    51 ROSUVASTATIN CALCIUM (1)

    52 ROSUVASTATIN CALCIUM (PRODUCT CODE 8004368) (1)

    53 SACUBITRIL SODIUM (1)

    54 SIMVASTATIN (1)

    55 SIMVASTATIN USP (1)

    56 SIROLIMUS DRUG SUBSTANCE (1)

    57 SITAGLIPTIN HYDROCHLORIDE (1)

    58 SITAGLIPTIN PHOSPHATE (1)

    59 SITAGLIPTIN PHOSPHATE MONOHYDRATE (1)

    60 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (1)

    61 SODIUM HEPARIN (1)

    62 TACROLIMUS (PRODUCT CODE 8000255) (1)

    63 TACROLIMUS GRANULES 20% W/W (1)

    64 TACROLIMUS USP (1)

    65 TEMSIROLIMUS (1)

    66 TERIFLUNOMIDE (1)

    67 TRAVOPROST USP DRUG SUBSTANCE (1)

    68 VALSARTAN DISODIUM (1)

    69 VILDAGLIPTIN (1)

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    01 BIOCON BIOCHEMICALS LTD (2)

    02 BIOCON BIOLOGICS INDIA LTD (2)

    03 BIOCON INDIA LTD (1)

    04 BIOCON LIMITED (1)

    05 BIOCON LTD (63)

    06 BIOCON SA (1)

    07 BIOCON SDN BHD (1)

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    01 India (71)

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    01 Active (59)

    02 Inactive (12)

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    01 Complete (46)

    02 Blank (25)

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    ANIDULAFUNGIN (DRUG SUBSTANCE INTER...

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    BIOCON LTD
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    2018-06-12
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    APIXABAN

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    BIOCON LTD
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    2021-02-08
    2020-11-27
    2020-12-31
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    ATORVASTATIN CALCIUM (USP) CRYSTALL...

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    BIOCON LTD
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    2014-04-18
    2014-04-15
    2011-08-26
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    ATORVASTATIN CALCIUM AMORPHOUS

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    BIOCON LTD
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    2008-07-29
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    ATORVASTATIN MAGNESIUM

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    20207
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    2007-01-16
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    BRINZOLAMIDE USP (STERILIZED)

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    BIOCON LTD
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    2015-12-15
    2015-09-22
    2015-09-25
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    COMPACTIN

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    BIOCON LTD
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    2002-07-12
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    DABIGATRAN ETEXILATE MESYLATE

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    BIOCON LTD
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    2018-11-19
    2018-09-19
    2018-09-28
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    DAPAGLIFLOZIN

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    BIOCON LTD
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    2017-08-01
    2017-06-14
    2017-07-03
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    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...

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    2021-06-29
    2021-07-05
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