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

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    Granules India Limited
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (AP)
    Telephone
    Telephone
    +91-40-30660000, +91-40-66760000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://granulesindia.com/
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    Linkedin
    https://in.linkedin.com/company/granules-india-limited
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    https://twitter.com/granulesindia?lang=en

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    • FDA
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    Abacavir sulfate

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R1-CEP 2016-113 - Rev 00
    Chemical
    2023-03-13
    2023-09-11
    2589
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    Atazanavir sulfate

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2020-279 - Rev 00
    Chemical
    2022-06-20
    2898
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    Capecitabine

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2019-091 - Rev 00
    Chemical
    2020-05-13
    2762
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    Cetirizine dihydrochloride

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2009-349 - Rev 01
    Chemical
    2016-05-26
    1084
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    Esomeprazole magnesium trihydrate

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2022-012 - Rev 00
    Chemical
    2022-11-30
    2372
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    Fluconazole

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2009-075 - Rev 01
    Chemical
    2018-04-11
    2287
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    Gabapentin

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R0-CEP 2019-167 - Rev 00
    Chemical
    2020-07-16
    2023-09-11
    2173
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    Gliclazide

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2017-240 - Rev 01
    Chemical
    2022-01-03
    1524
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    Guaifenesin

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2009-201 - Rev 03
    Chemical
    2018-11-27
    615
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    Guaifenesin, BPL site

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2021-332 - Rev 00
    Chemical
    2021-12-10
    615
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    • FDA
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    Losartan potassium

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2009-194 - Rev 05
    Chemical
    2022-01-12
    2232
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    Losartan potassium, Process II

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    GRANULES INDIA LIMITED ...
    Valid
    CEP 2020-333 - Rev 02
    Chemical
    2023-11-09
    2232
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    Metformin Hydrochloride

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2004-124 - Rev 07
    Chemical
    2023-05-05
    931
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    Metformin Hydrochloride, BPL Site

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    GRANULES INDIA LIMITED ...
    Valid
    CEP 2018-120 - Rev 01
    Chemical
    2023-12-12
    931
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    Metformin Hydrochloride, Unit-IV Site

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2021-312 - Rev 00
    Chemical
    2022-01-18
    931
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    Metoprolol succinate

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2019-232 - Rev 01
    Chemical
    2023-05-03
    1448
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    Naproxen sodium

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R0-CEP 2020-106 - Rev 00
    Chemical
    2021-06-28
    2023-09-11
    1702
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    Oxymetazoline hydrochloride

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R0-CEP 2004-292 - Rev 01
    Chemical
    2008-12-12
    2013-04-19
    943
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    Pantoprazole sodium sesquihydrate

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R1-CEP 2011-116 - Rev 01
    Chemical
    2017-07-07
    2023-09-11
    2296
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    Paracetamol

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 1998-047 - Rev 06
    Chemical
    2018-01-19
    49
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    Penicillamine

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2020-391 - Rev 00
    Chemical
    2023-01-17
    566
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    Pirfenidone

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2016-288 - Rev 00
    Chemical
    2022-12-05
    2856
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    Rifaximin

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    GRANULES INDIA LIMITED ...
    Valid
    R1-CEP 2012-146 - Rev 01
    Chemical
    2020-02-19
    2362
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    Rifaximin, [RSA code] Process-II

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    GRANULES INDIA LIMITED ...
    Valid
    R0-CEP 2021-377 - Rev 00
    Chemical
    2023-02-16
    2362
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    Telmisartan

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R0-CEP 2011-355 - Rev 01
    Chemical
    2015-01-29
    2018-01-03
    2154
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    Trazodone hydrochloride

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    GRANULES INDIA LIMITED ...
    Valid
    CEP 2023-010 - Rev 00
    Chemical
    2024-02-15
    2857
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    Valsartan

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    GRANULES INDIA LIMITED ...
    Withdrawn by Holder
    R0-CEP 2013-012 - Rev 00
    Chemical
    2015-03-05
    2018-01-03
    2423
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