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

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    Biocon
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    Country
    Country
    India
    Address
    Address
    20th KM, Hosur Road,Electronics City,Bangalore
    Telephone
    Telephone
    +91 80 2808 2808 / 91 80 4014 4014
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.biocon.com/
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    https://www.linkedin.com/company-beta/162713/
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    https://twitter.com/Bioconlimited

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    • FDA
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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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    Fluvastatin sodium, Crystalline-2

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-130 - Rev 01
    Chemical
    2022-06-23
    2333
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    Lovastatin

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    BIOCON LIMITED Bangalor...
    Withdrawn by Holder
    R0-CEP 2001-354 - Rev 02
    Chemical
    2004-10-11
    2007-10-18
    1538
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    Lovastatin

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    BIOCON LIMITED Bangalor...
    Withdrawn by Holder
    R1-CEP 2003-128 - Rev 03
    Chemical
    2013-07-11
    2021-04-16
    1538
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    Mycophenolate mofetil

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    BIOCON LIMITED Bangalor...
    Valid
    R1-CEP 2007-052 - Rev 00
    Chemical
    2013-07-09
    1700
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    Mycophenolate mofetil, Process II

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2010-162 - Rev 08
    Chemical
    2024-01-04
    1700
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    Mycophenolate sodium

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-019 - Rev 00
    Chemical
    2023-06-06
    2813
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    Pioglitazone hydrochloride

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    BIOCON LIMITED Bangalor...
    Valid
    R1-CEP 2012-340 - Rev 00
    Chemical
    2018-10-31
    2601
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    Pioglitazone hydrochloride, Process I

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2014-351 - Rev 00
    Chemical
    2021-09-23
    2601
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    Pravastatin sodium

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    BIOCON LIMITED Bangalor...
    Valid
    R1-CEP 2002-177 - Rev 02
    Chemical
    2013-06-13
    2059
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    Pravastatin sodium, Product Code 8000070

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2004-085 - Rev 05
    Chemical
    2020-05-14
    2059
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    Repaglinide

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    BIOCON LIMITED Bangalor...
    Valid
    R1-CEP 2008-093 - Rev 01
    Chemical
    2018-08-20
    2135
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    Rivaroxaban

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2022-144 - Rev 00
    Chemical
    2023-07-20
    2932
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    Rosuvastatin calcium

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2015-040 - Rev 00
    Chemical
    2020-12-10
    2631
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    Rosuvastatin calcium, Process I

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    BIOCON LIMITED Bengalur...
    Valid
    R1-CEP 2015-114 - Rev 02
    Chemical
    2023-01-27
    2631
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    Simvastatin

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2012-337 - Rev 03
    Chemical
    2024-01-26
    1563
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    Simvastatin

    PDF Supplier PDF
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    BIOCON LIMITED Bangalor...
    Withdrawn by Holder
    R1-CEP 2001-388 - Rev 02
    Chemical
    2012-11-22
    2019-03-25
    1563
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    Simvastatin, Butylated hydroxyanisole 0.01%, Process I...

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    BIOCON LIMITED Bangalor...
    Withdrawn by Holder
    R1-CEP 2005-243 - Rev 00
    Chemical
    2012-02-28
    2019-03-25
    1563
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    Simvastatin, Butylated Hydroxyanisole 0.01%

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2003-131 - Rev 12
    Chemical
    2023-11-08
    1563
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    • FDA
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    Sitagliptin phosphate monohydrate

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    BIOCON LIMITED Bengalur...
    Valid
    R0-CEP 2020-197 - Rev 00
    Chemical
    2023-08-11
    2778
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    Tacrolimus monohydrate

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2017-257 - Rev 01
    Chemical
    2023-11-29
    2244
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    Sitagliptin phosphate monohydrate, Process-II

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    BIOCON LIMITED Bengalur...
    Valid
    CEP 2023-366 - Rev 00
    Chemical
    2024-03-20
    2778
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