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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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    • 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 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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    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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    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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    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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    Everolimus (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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    Everolimus EP

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    M/s Biocon Limited
    WC-0100A7
    2022-07-02
    2020-08-17
    SEZ, Plot No 2,3,4 & 5, Phase-iV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru-560099 I...
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    FIDAXOMICIN 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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    Fidaxomicin

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    M/s. Biocon Limited
    WC-100(2)
    2019-07-02
    2018-12-24
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099
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    Fluvastatin Sodium (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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    Glatiramer Acetate 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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    Ivabradine Hydrochloride IH

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    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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    Lenalidomide IHS

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    M/s Biocon Limited
    WC-0405A2
    2022-03-14
    2021-05-28
    Plot No.2-4,Road No J N Pharma City thadi village, IDA Paravada, Vishakhapatnam, Andhra pradesh-5310...
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    Linagliptin 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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    Lovastatin (Ph.Eur

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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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    MICAFUNGIN SODIUM 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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    Micafungin Sodium

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    M/s. Biocon Limited
    WC-0100(3)
    2019-07-02
    2018-12-10
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099
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    Mirabegron IH

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    M/s Biocon Limited
    WC-0100A8
    2022-07-02
    2021-01-15
    SEZ, Plot No 2,3,4 & 5, Phase-iV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru-560099 I...
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    Mycophenolate Mofetil (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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    Mycophenolate Mofetil IP/USP/EP/BP/IH

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    M/s Biocon Limited
    WC-0405
    2022-03-14
    2019-09-03
    Plot No.2-4,Road No J N Pharma City thadi village, IDA Paravada, Vishakhapatnam, Andhra pradesh-5310...
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    Mycophenolate Sodium

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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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    Mycophenolate Sodium USP

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    M/s Biocon Limited
    WC-0109A3
    2022-07-02
    2019-10-30
    (Site 1), 20th KM, Hosur Road, Electronic City, Banglore-560 100
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    Orlistat USP

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    M/s Biocon Limited
    WC-0100A
    2022-07-02
    2019-10-30
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099
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    Orlistat (IH/USP)

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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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    Pimecrolimus

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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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    Pioglitazone Hydrochloride (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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    Posaconazole 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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    Pravastatin Sodium (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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    Pravastatin Sodium (Ph.Eur)

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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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    Repaglinide (EP/USP)

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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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    Rosuvastatin Calcium

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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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    Rosuvastatin Calcium IH/USP/EP

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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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    Simvastatin (EP/USP)

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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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    Simvastatin (Ph.Eur/USP)

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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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    Simvastatin EP/USP

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    M/s Biocon Limited
    WC-0109A3
    2022-07-02
    2019-10-30
    (Site 1), 20th KM, Hosur Road, Electronic City, Banglore-560 100
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    Sirolimus

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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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    Sitagliptin Phosphate IH/USP

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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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    Tacrolimus, (USP)/Tacrolimus Monohydrate 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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    Temsirolimus (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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    Vildagliptin 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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    Vildagliptin IH

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    M/s. Biocon Limited
    WC-0100-(1)
    2019-07-02
    2019-05-21
    Site 2, Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore-560 099
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