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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Biocon by EDQM. Original Data: EDQM Database

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    01 Atorvastatin calcium, Crystalline (1)

    02 Deferasirox (1)

    03 Everolimus, 0.2% BHT (1)

    04 Everolimus, 0.2% BHT-II (1)

    05 Everolimus, 2% BHT (1)

    06 Everolimus, 2% BHT-II (1)

    07 Fingolimod hydrochloride (1)

    08 Fluvastatin sodium, Amorphous (1)

    09 Fluvastatin sodium, Amorphous-2 (1)

    10 Fluvastatin sodium, Crystalline (1)

    11 Fluvastatin sodium, Crystalline-2 (1)

    12 Lovastatin (2)

    13 Mycophenolate mofetil (1)

    14 Mycophenolate mofetil, Process II (1)

    15 Mycophenolate sodium (1)

    16 Pioglitazone hydrochloride (1)

    17 Pioglitazone hydrochloride, Process I (1)

    18 Pravastatin sodium (1)

    19 Pravastatin sodium, Product Code 8000070 (1)

    20 Repaglinide (1)

    21 Rivaroxaban (1)

    22 Rosuvastatin calcium (1)

    23 Rosuvastatin calcium, Process I (1)

    24 Simvastatin (2)

    25 Simvastatin, Butylated Hydroxyanisole 0.01% (1)

    26 Simvastatin, Butylated hydroxyanisole 0.01%, Process II (1)

    27 Sitagliptin phosphate monohydrate (1)

    28 Sitagliptin phosphate monohydrate, Process-II (1)

    29 Tacrolimus monohydrate (1)

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    01 BIOCON LIMITED Bangalore IN (8)

    02 BIOCON LIMITED Bengaluru IN (23)

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    01 India (31)

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    01 Valid (27)

    02 Withdrawn by Holder (4)

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    Atorvastatin calcium, Crystalline

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2011-009 - Rev 03
    Chemical
    2022-12-08
    2191
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    Deferasirox

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2022-080 - Rev 00
    Chemical
    2024-03-20
    2933
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    Everolimus, 0.2% BHT

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2019-323 - Rev 00
    Chemical
    2022-01-31
    2918
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    Everolimus, 0.2% BHT-II

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-235 - Rev 00
    Chemical
    2022-08-26
    2918
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    Everolimus, 2% BHT

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2020-072 - Rev 01
    Chemical
    2023-04-19
    2918
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    Everolimus, 2% BHT-II

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-143 - Rev 00
    Chemical
    2022-08-31
    2918
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    Fingolimod hydrochloride

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2020-156 - Rev 02
    Chemical
    2023-09-15
    2988
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    Fluvastatin sodium, Amorphous

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2016-075 - Rev 00
    Chemical
    2022-10-14
    2333
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    Fluvastatin sodium, Amorphous-2

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-139 - Rev 01
    Chemical
    2022-08-08
    2333
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    Fluvastatin sodium, Crystalline

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2018-182 - Rev 02
    Chemical
    2024-03-25
    2333
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