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    List of Active Pharmaceutical Ingredients (APIs) for which Written Confirmation(s) have been obtained by Biocon Limited

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    01 Apixaban IHS (1)

    02 Atorvastatin Calcium (1H) (1)

    03 Atorvastatin Calcium Trihydrate (EP) (1)

    04 Atorvastatin Magnesium (IH) (1)

    05 Brinzolamide USP (1)

    06 Dabigatran etexilate mesilate IH (1)

    07 Dapagliflozin IH (1)

    08 Dapagliflozin Propanediol IHS (1)

    09 Deferasirox IH (1)

    10 Everolimus (IH) (1)

    11 Everolimus EP (1)

    12 FIDAXOMICIN IH (1)

    13 Fidaxomicin (1)

    14 Fluvastatin Sodium (EP) (1)

    15 Glatiramer Acetate IH (1)

    16 Ivabradine Hydrochloride IH (1)

    17 Lenalidomide IHS (1)

    18 Linagliptin IH (1)

    19 Lovastatin (Ph.Eur (1)

    20 MICAFUNGIN SODIUM IH (1)

    21 Micafungin Sodium (1)

    22 Mirabegron IH (1)

    23 Mycophenolate Mofetil (EP) (1)

    24 Mycophenolate Mofetil IP/USP/EP/BP/IH (1)

    25 Mycophenolate Sodium (1)

    26 Mycophenolate Sodium USP (1)

    27 Orlistat (IH/USP) (1)

    28 Orlistat USP (1)

    29 Pimecrolimus (1)

    30 Pioglitazone Hydrochloride (IH) (1)

    31 Posaconazole IH (1)

    32 Pravastatin Sodium (EP) (1)

    33 Pravastatin Sodium (Ph.Eur) (1)

    34 Repaglinide (EP/USP) (1)

    35 Rosuvastatin Calcium (1)

    36 Rosuvastatin Calcium IH/USP/EP (1)

    37 Simvastatin (EP/USP) (1)

    38 Simvastatin (Ph.Eur/USP) (1)

    39 Simvastatin EP/USP (1)

    40 Sirolimus (1)

    41 Sitagliptin Phosphate IH/USP (1)

    42 Sitagliptin Phosphate Monohydrate EP (1)

    43 Tacrolimus, (USP)/Tacrolimus Monohydrate EP (1)

    44 Temsirolimus (IH) (1)

    45 Vildagliptin IH (2)

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    01 Biocon Limited (2)

    02 M/s Biocon Limited (10)

    03 M/s. Biocon Limited (22)

    04 M/s. Biocon Limited  (12)

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    01 WC-0038 (8)

    02 WC-0038A2 (3)

    03 WC-0100 (12)

    04 WC-0100(3) (1)

    05 WC-0100-(1) (1)

    06 WC-0100-A5 (2)

    07 WC-0100A (1)

    08 WC-0100A7 (1)

    09 WC-0100A8 (1)

    10 WC-0109 (11)

    11 WC-0109A3 (2)

    12 WC-0405 (1)

    13 WC-0405A2 (1)

    14 WC-100(2) (1)

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    01 India (46)

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    • FDA
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    Apixaban IHS

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    M/s Biocon Limited
    WC-0038A2
    2022-08-04
    2022-02-18
    Plot No.213, 214 & 216/B, IDA Phase II, Pashamylaram, Sangareddy (district), Telangana state 502307,...
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    Atorvastatin Calcium Trihydrate (EP)

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    M/s. Biocon Limited
    WC-0109
    2025-07-02
    2022-04-13
    (Site 1), 20th KM, Hosur Road, Electronic City, Banglore-560 100 
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    Atorvastatin Magnesium (IH)

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    M/s. Biocon Limited 
    WC-0100
    2022-07-02
    2019-07-22
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099 
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    Atorvastatin Calcium (1H)

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    M/s. Biocon Limited 
    WC-0100
    2022-07-02
    2019-07-22
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099 
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    Brinzolamide USP

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    M/s Biocon Limited
    WC-0038A2
    2022-08-04
    2022-02-18
    Plot No.213, 214 & 216/B, IDA Phase II, Pashamylaram, Sangareddy (district), Telangana state 502307,...
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    Sitagliptin Phosphate Monohydrate EP

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    Biocon Limited
    WC-0100-A5
    2022-07-02
    2020-01-28
    SEZ, Plot No 2,3,4 & 5, Phase-iV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru-560099
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    Dabigatran etexilate mesilate IH

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    M/s. Biocon Limited
    WC-0038
    2022-08-04
    2019-09-09
    Plot No.213, 214 & 215, I.D.A. Phase-II, Pashamylaram, Medak Dist, A.P
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    Dapagliflozin IH

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    M/s. Biocon Limited
    WC-0038
    2022-08-04
    2019-09-09
    Plot No.213, 214 & 215, I.D.A. Phase-II, Pashamylaram, Medak Dist, A.P
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    Dapagliflozin Propanediol IHS

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    M/s Biocon Limited
    WC-0038A2
    2022-08-04
    2022-02-18
    Plot No.213, 214 & 216/B, IDA Phase II, Pashamylaram, Sangareddy (district), Telangana state 502307,...
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    Deferasirox IH

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    M/s. Biocon Limited
    WC-0038
    2022-08-04
    2019-09-09
    Plot No.213, 214 & 215, I.D.A. Phase-II, Pashamylaram, Medak Dist, A.P
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