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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Granules India Limited

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    Granules India Limited
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    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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    • FDA
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    Metformin

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    USDMF

    Found USDMF

    16625
    Active
    METFORMIN HYDROCHLORIDE USP
    2003-06-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-124 - Rev 07
    Valid
    Metformin Hydrochloride
    2023-05-05
    Japanese DMF

    Found JDMF

    305MF10066
    Metformin Hydrochloride at 2nd Floo...
    2023-05-24
    Written Confirmation

    Found WC

    Indian CDSCO WC-0028
    Valid
    Metformin HCl (Ph. Eur./ USP)
    2022-06-30
    Application Number
    16625
    R1-CEP 2004-124 - Rev 07
    305MF10066
    Indian CDSCO WC-0028
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METFORMIN HYDROCHLORIDE USP
    Metformin Hydrochloride
    Metformin Hydrochloride at 2nd Floo...
    Metformin HCl (Ph. Eur./ USP)
    Issue/Submission Date
    2003-06-06
    2023-05-05
    2023-05-24
    2022-06-30
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    • FDA
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    Paracetamol

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    USDMF

    Caution USDMF

    11436
    Inactive
    COMPRESSO-90-P (ACETAMINOPHEN GRANU...
    1995-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-047 - Rev 06
    Valid
    Paracetamol
    2018-01-19
    Japanese DMF

    Found JDMF

    228MF10061
    Acetaminophen at 2nd Floor, 3rd Blo...
    2016-02-24
    Written Confirmation

    Found WC

    Indian CDSCO WC-0116
    Valid
    Acetaminophen (USP) /Paracetamol (...
    2022-06-29
    Application Number
    11436
    R1-CEP 1998-047 - Rev 06
    228MF10061
    Indian CDSCO WC-0116
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    COMPRESSO-90-P (ACETAMINOPHEN GRANU...
    Paracetamol
    Acetaminophen at 2nd Floor, 3rd Blo...
    Acetaminophen (USP) /Paracetamol (...
    Issue/Submission Date
    1995-04-05
    2018-01-19
    2016-02-24
    2022-06-29
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    • FDA
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    Atazanavir Sulfate

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    USDMF

    Found USDMF

    32259
    Active
    ATAZANAVIR SULFATE
    2017-12-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-279 - Rev 00
    Valid
    Atazanavir sulfate
    2022-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    ATAZANAVIR SULPHATE IH/EP
    2022-07-08
    Application Number
    32259
    R0-CEP 2020-279 - Rev 00
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-28
    Filing Details
    ATAZANAVIR SULFATE
    Atazanavir sulfate
    ATAZANAVIR SULPHATE IH/EP
    Issue/Submission Date
    2017-12-27
    2022-06-20
    2022-07-08
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    • FDA
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    30063
    Active
    CETIRIZINE HYDROCHLORIDE, USP
    2016-02-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-349 - Rev 01
    Valid
    Cetirizine dihydrochloride
    2016-05-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Cetrizine Dihydrochloride EP
    2022-07-08
    Application Number
    30063
    R1-CEP 2009-349 - Rev 01
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-28
    Filing Details
    CETIRIZINE HYDROCHLORIDE, USP
    Cetirizine dihydrochloride
    Cetrizine Dihydrochloride EP
    Issue/Submission Date
    2016-02-01
    2016-05-26
    2022-07-08
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    • FDA
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    Guaifenesin

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    USDMF

    Found USDMF

    14372
    Active
    GUAIFENESIN USP
    1999-08-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-201 - Rev 03
    Valid
    Guaifenesin
    2018-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0028
    Valid
    Guaifenesin (USP/Ph.Eur)
    2022-06-30
    Application Number
    14372
    R1-CEP 2009-201 - Rev 03
    Indian CDSCO WC-0028
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GUAIFENESIN USP
    Guaifenesin
    Guaifenesin (USP/Ph.Eur)
    Issue/Submission Date
    1999-08-30
    2018-11-27
    2022-06-30
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    • FDA
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    Losartan Potassium

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    USDMF

    Found USDMF

    22711
    Active
    LOSARTAN POTASSIUM USP
    2009-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-194 - Rev 05
    Valid
    Losartan potassium
    2022-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Losartan Potassium EP
    2022-07-08
    Application Number
    22711
    R1-CEP 2009-194 - Rev 05
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-28
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan Potassium EP
    Issue/Submission Date
    2009-04-02
    2022-01-12
    2022-07-08
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    • FDA
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    Metformin

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    USDMF

    Found USDMF

    17723
    Active
    COMPRESSO 95P
    2004-09-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-312 - Rev 00
    Valid
    Metformin Hydrochloride, Unit-IV Si...
    2022-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0116
    Valid
    Metformin Hydrochloride IP/BP/EP/US...
    2022-06-29
    Application Number
    17723
    R0-CEP 2021-312 - Rev 00
    Indian CDSCO WC-0116
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    COMPRESSO 95P
    Metformin Hydrochloride, Unit-IV Si...
    Metformin Hydrochloride IP/BP/EP/US...
    Issue/Submission Date
    2004-09-22
    2022-01-18
    2022-06-29
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    • FDA
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    33544
    Active
    METOPROLOL SUCCINATE USP
    2019-03-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-232 - Rev 01
    Valid
    Metoprolol succinate
    2023-05-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0526
    Valid
    Metoprolol Succinate EP/USP
    2022-05-02
    Application Number
    33544
    R0-CEP 2019-232 - Rev 01
    Indian CDSCO WC-0526
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-05-01
    Filing Details
    METOPROLOL SUCCINATE USP
    Metoprolol succinate
    Metoprolol Succinate EP/USP
    Issue/Submission Date
    2019-03-27
    2023-05-03
    2022-05-02
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    • FDA
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    Pirfenidone

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    USDMF

    Found USDMF

    30922
    Active
    PIRFENIDONE
    2016-09-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-288 - Rev 00
    Valid
    Pirfenidone
    2022-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Pirfenidone IH/EP
    2022-07-08
    Application Number
    30922
    R1-CEP 2016-288 - Rev 00
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-28
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone IH/EP
    Issue/Submission Date
    2016-09-30
    2022-12-05
    2022-07-08
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    • FDA
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    Trazodone Hydrochloride

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    USDMF

    Found USDMF

    37593
    Active
    TRAZODONE HYDROCHLORIDE USP
    2022-12-28
    CEP/COS

    Found CEP/COS

    CEP 2023-010 - Rev 00
    Valid
    Trazodone hydrochloride
    2024-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Trazodone HydrochlorideIH/USP
    2022-07-08
    Application Number
    37593
    CEP 2023-010 - Rev 00
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-28
    Filing Details
    TRAZODONE HYDROCHLORIDE USP
    Trazodone hydrochloride
    Trazodone HydrochlorideIH/USP
    Issue/Submission Date
    2022-12-28
    2024-02-15
    2022-07-08
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    • FDA
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    Fluconazole

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    USDMF

    Caution USDMF

    22710
    Inactive
    FLUCONAZOLE USP
    2009-03-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-075 - Rev 01
    Valid
    Fluconazole
    2018-04-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Fluconazol EP
    2022-07-08
    Application Number
    22710
    R1-CEP 2009-075 - Rev 01
    Indian CDSCO WC-0024
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-28
    Filing Details
    FLUCONAZOLE USP
    Fluconazole
    Fluconazol EP
    Issue/Submission Date
    2009-03-30
    2018-04-11
    2022-07-08
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    • FDA
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    Rifaximin

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    USDMF

    Caution USDMF

    32351
    Inactive
    RIFAXIMIN
    2018-03-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-146 - Rev 01
    Valid
    Rifaximin
    2020-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Rifaximin EP
    2022-07-08
    Application Number
    32351
    R1-CEP 2012-146 - Rev 01
    Indian CDSCO WC-0024
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-28
    Filing Details
    RIFAXIMIN
    Rifaximin
    Rifaximin EP
    Issue/Submission Date
    2018-03-30
    2020-02-19
    2022-07-08
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    • FDA
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-091 - Rev 00
    Valid
    Capecitabine
    2020-05-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0526
    Valid
    Capecitabine EP
    2022-05-02
    Application Number
    R0-CEP 2019-091 - Rev 00
    Indian CDSCO WC-0526
    Status
    Valid
     
    Valid
    2025-05-01
    Filing Details
    Capecitabine
    Capecitabine EP
    Issue/Submission Date
    2020-05-13
    2022-05-02
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    • FDA
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    Dimethyl Fumarate

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    USDMF

    Found USDMF

    30938
    Active
    DIMETHYL FUMARATE
    2016-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Dimethyl Fumarate IH
    2022-07-08
    Application Number
    30938
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-28
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate IH
    Issue/Submission Date
    2016-09-27
    2022-07-08
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    • FDA
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    Eltrombopag

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    USDMF

    Found USDMF

    34069
    Active
    ELTROMBOPAG OLAMINE
    2019-10-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0526
    Valid
    Eltrombopag Olamine IH
    2022-05-02
    Application Number
    34069
    Indian CDSCO WC-0526
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-05-01
    Filing Details
    ELTROMBOPAG OLAMINE
    Eltrombopag Olamine IH
    Issue/Submission Date
    2019-10-02
    2022-05-02
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    • FDA
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    36556
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
    2021-12-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-012 - Rev 00
    Valid
    Esomeprazole magnesium trihydrate
    2022-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36556
    R0-CEP 2022-012 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
    Esomeprazole magnesium trihydrate
    Issue/Submission Date
    2021-12-24
    2022-11-30
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    • FDA
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    Gabapentin

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    USDMF

    Caution USDMF

    33536
    Inactive
    GABAPENTIN USP
    2019-03-20
    CEP/COS

    Caution CEP/COS

    R0-CEP 2019-167 - Rev 00
    Withdrawn by Holder
    Gabapentin
    2020-07-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    GabapentinEP
    2022-07-08
    Application Number
    33536
    R0-CEP 2019-167 - Rev 00
    Indian CDSCO WC-0024
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Valid
    2025-06-28
    Filing Details
    GABAPENTIN USP
    Gabapentin
    GabapentinEP
    Issue/Submission Date
    2019-03-20
    2020-07-16
    2022-07-08
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    Gliclazide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2017-240 - Rev 01
    Valid
    Gliclazide
    2022-01-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Gliclazide IP/IH/EP/BP
    2022-07-08
    Application Number
    R0-CEP 2017-240 - Rev 01
    Indian CDSCO WC-0024
    Status
    Valid
     
    Valid
    2025-06-28
    Filing Details
    Gliclazide
    Gliclazide IP/IH/EP/BP
    Issue/Submission Date
    2022-01-03
    2022-07-08
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    Guaifenesin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20998
    Active
    COMPRESSO GGF 95 SA (GUAIFENESIN GR...
    2007-10-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-332 - Rev 00
    Valid
    Guaifenesin, BPL site
    2021-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20998
    R0-CEP 2021-332 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    COMPRESSO GGF 95 SA (GUAIFENESIN GR...
    Guaifenesin, BPL site
    Issue/Submission Date
    2007-10-31
    2021-12-10
    ASK
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    • FDA
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    Levocetirizine Dihydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    22898
    Active
    LEVOCETIRIZINE DIHYDROCHLORIDE USP
    2009-05-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Levocetirizine Dihydrochloride IH
    2022-07-08
    Application Number
    22898
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-28
    Filing Details
    LEVOCETIRIZINE DIHYDROCHLORIDE USP
    Levocetirizine Dihydrochloride IH
    Issue/Submission Date
    2009-05-22
    2022-07-08
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    Losartan Potassium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36088
    Active
    COMPRESSO LSP 33.333 % (LOSARTAN PO...
    2021-07-12
    CEP/COS

    Found CEP/COS

    CEP 2020-333 - Rev 02
    Valid
    Losartan potassium, Process II
    2023-11-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36088
    CEP 2020-333 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    COMPRESSO LSP 33.333 % (LOSARTAN PO...
    Losartan potassium, Process II
    Issue/Submission Date
    2021-07-12
    2023-11-09
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    Metformin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2018-120 - Rev 01
    Valid
    Metformin Hydrochloride, BPL Site
    2023-12-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Metformin Hydrochloride IP/IH/EP/US...
    2022-07-08
    Application Number
    CEP 2018-120 - Rev 01
    Indian CDSCO WC-0024
    Status
    Valid
     
    Valid
    2025-06-28
    Filing Details
    Metformin Hydrochloride, BPL Site
    Metformin Hydrochloride IP/IH/EP/US...
    Issue/Submission Date
    2023-12-12
    2022-07-08
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    Methocarbamol

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    USDMF

    Found USDMF

    17872
    Active
    METHOCARBAMOL USP
    2004-12-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0028
    Valid
    Methocarbamol (USP)
    2022-06-30
    Application Number
    17872
    Indian CDSCO WC-0028
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    METHOCARBAMOL USP
    Methocarbamol (USP)
    Issue/Submission Date
    2004-12-03
    2022-06-30
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    Naproxen Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    34691
    Inactive
    NAPROXEN SODIUM, USP
    2020-04-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2020-106 - Rev 00
    Withdrawn by Holder
    Naproxen sodium
    2021-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Naproxen sodium salt IP/EP
    2022-07-08
    Application Number
    34691
    R0-CEP 2020-106 - Rev 00
    Indian CDSCO WC-0024
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Valid
    2025-06-28
    Filing Details
    NAPROXEN SODIUM, USP
    Naproxen sodium
    Naproxen sodium salt IP/EP
    Issue/Submission Date
    2020-04-01
    2021-06-28
    2022-07-08
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    36865
    Active
    OLMESARTAN MEDOXOMIL USP
    2022-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Olmesartan Medoxomil USP/EP
    2022-07-08
    Application Number
    36865
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-06-28
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan Medoxomil USP/EP
    Issue/Submission Date
    2022-03-31
    2022-07-08
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    Omeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31829
    Active
    OMEPRAZOLE MAGNESIUM USP
    2017-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Omeprazole Magnesium IH/USP
    2022-07-08
    Application Number
    31829
    Indian CDSCO WC-0024
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-28
    Filing Details
    OMEPRAZOLE MAGNESIUM USP
    Omeprazole Magnesium IH/USP
    Issue/Submission Date
    2017-08-31
    2022-07-08
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    Penicillamine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31922
    Active
    PENICILLAMINE, USP
    2017-11-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-391 - Rev 00
    Valid
    Penicillamine
    2023-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31922
    R0-CEP 2020-391 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PENICILLAMINE, USP
    Penicillamine
    Issue/Submission Date
    2017-11-03
    2023-01-17
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    Rifaximin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36125
    Active
    RIFAXIMIN (RSA CODE)
    2021-08-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-377 - Rev 00
    Valid
    Rifaximin, [RSA code] Process-II
    2023-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36125
    R0-CEP 2021-377 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RIFAXIMIN (RSA CODE)
    Rifaximin, [RSA code] Process-II
    Issue/Submission Date
    2021-08-29
    2023-02-16
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    • FDA
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    Abacavir Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2016-113 - Rev 00
    Withdrawn by Holder
    Abacavir sulfate
    2023-03-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0024
    Valid
    Abacavir Sulphate EP
    2022-07-08
    Application Number
    R1-CEP 2016-113 - Rev 00
    Indian CDSCO WC-0024
    Status
    Withdrawn by Holder
     
    Valid
    2025-06-28
    Filing Details
    Abacavir sulfate
    Abacavir Sulphate EP
    Issue/Submission Date
    2023-03-13
    2022-07-08
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    Bortezomib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34445
    Active
    BORTEZOMIB
    2020-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34445
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BORTEZOMIB
    Issue/Submission Date
    2020-01-31
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    Bupropion Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35694
    Active
    BUPROPION HYDROCHLORIDE USP
    2021-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35694
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPROPION HYDROCHLORIDE USP
    Issue/Submission Date
    2021-03-29
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    Dasatinib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35270
    Active
    DASATINIB
    2020-11-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35270
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DASATINIB
    Issue/Submission Date
    2020-11-23
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    Esomeprazole Magnesium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37233
    Active
    ESOMEPRAZOLE MAGNESIUM DELAYED-RELE...
    2022-07-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37233
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DELAYED-RELE...
    Issue/Submission Date
    2022-07-01
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    • FDA
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    Fexofenadine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30604
    Active
    FEXOFENADINE HYDROCHLORIDE, USP
    2016-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30604
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FEXOFENADINE HYDROCHLORIDE, USP
    Issue/Submission Date
    2016-08-16
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    Ibuprofen

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20606
    Active
    COMPRESSO IBU 66S
    2007-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20606
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPRESSO IBU 66S
    Issue/Submission Date
    2007-06-12
    ASK
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    Ibuprofen

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35886
    Active
    COMPRESSO IBU 85 PAR (IBUPROFEN GRA...
    2021-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35886
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPRESSO IBU 85 PAR (IBUPROFEN GRA...
    Issue/Submission Date
    2021-05-18
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    • FDA
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    Lapatinib Ditosylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36602
    Active
    LAPATINIB DITOSYLATE MONOHYDRATE
    2022-01-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36602
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LAPATINIB DITOSYLATE MONOHYDRATE
    Issue/Submission Date
    2022-01-24
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    • FDA
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    Melphalan Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36096
    Active
    MELPHALAN HYDROCHLORIDE
    2021-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36096
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELPHALAN HYDROCHLORIDE
    Issue/Submission Date
    2021-07-23
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    • FDA
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    Metoprolol Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35959
    Active
    METOPROLOL SUCCINATE MICROSPHERES 9...
    2021-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35959
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METOPROLOL SUCCINATE MICROSPHERES 9...
    Issue/Submission Date
    2021-06-13
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    • FDA
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    Nilotinib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37531
    Active
    NILOTINIB HYDROCHLORIDE MONOHYDRATE
    2022-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37531
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NILOTINIB HYDROCHLORIDE MONOHYDRATE
    Issue/Submission Date
    2022-09-30
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    Omeprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37449
    Active
    Omeprazole USP
    2022-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37449
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    Omeprazole USP
    Issue/Submission Date
    2022-09-29
    ASK
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    • FDA
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    Pantoprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36849
    Active
    Pantoprazole Sodium Sesquihydrate, ...
    2022-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36849
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    Pantoprazole Sodium Sesquihydrate, ...
    Issue/Submission Date
    2022-05-19
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    • FDA
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    Paracetamol

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    17722
    Active
    COMPRESSO PAP 90 CPF
    2004-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17722
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPRESSO PAP 90 CPF
    Issue/Submission Date
    2004-09-22
    ASK
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    Paracetamol

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    18978
    Active
    COMPRESSO PAP 90 CPL
    2005-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18978
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPRESSO PAP 90 CPL
    Issue/Submission Date
    2005-11-28
    ASK
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    Paracetamol

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    19804
    Active
    ACETAMINOPHEN USP
    2006-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19804
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACETAMINOPHEN USP
    Issue/Submission Date
    2006-09-28
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    Paracetamol

    PDF Supplier PDF
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    See all info for this product

    See Less

    USDMF

    Found USDMF

    19972
    Active
    COMPRESSO PAP 90 CPC
    2006-11-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19972
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPRESSO PAP 90 CPC
    Issue/Submission Date
    2006-11-16
    ASK
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    • FDA
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    Pazopanib Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36037
    Active
    PAZOPANIB HYDROCHLORIDE
    2021-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36037
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PAZOPANIB HYDROCHLORIDE
    Issue/Submission Date
    2021-06-30
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    • FDA
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    Prazosin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35210
    Active
    PRAZOSIN HYDROCHLORIDE USP
    2020-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35210
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRAZOSIN HYDROCHLORIDE USP
    Issue/Submission Date
    2020-09-30
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    • FDA
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    Sorafenib

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