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

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    01 Abacavir Sulfate (1)

    02 Atazanavir Sulfate (3)

    03 Azathioprine (1)

    04 Azithromycin (2)

    05 Benzyl Penicillin (1)

    06 Bortezomib (1)

    07 Brinzolamide (1)

    08 Brompheniramine Maleate (1)

    09 Bupropion Hydrochloride (1)

    10 Capecitabine (1)

    11 Cetirizine Dihydrochloride (1)

    12 Chlorpheniramine Maleate (1)

    13 Clopidogrel (1)

    14 Darunavir (1)

    15 Dasatinib (2)

    16 Dimethyl Fumarate (1)

    17 Eltrombopag (1)

    18 Esomeprazole Magnesium (2)

    19 Fexofenadine Hydrochloride (1)

    20 Fluconazole (1)

    21 Gabapentin (1)

    22 Gliclazide (1)

    23 Guaifenesin (2)

    24 Ibuprofen (2)

    25 Itraconazole (1)

    26 Lapatinib Ditosylate (1)

    27 Levetiracetam (1)

    28 Levocetirizine Dihydrochloride (1)

    29 Losartan Potassium (2)

    30 Melphalan Hydrochloride (1)

    31 Metformin (3)

    32 Methocarbamol (1)

    33 Metoprolol Succinate (2)

    34 Mycophenolate Mofetil Hydrochloride (1)

    35 Naproxen Sodium (2)

    36 Nilotinib (1)

    37 Olmesartan Medoxomil (2)

    38 Omeprazole (1)

    39 Omeprazole Magnesium (2)

    40 Oxymetazoline Hydrochloride (1)

    41 Pantoprazole Sodium (2)

    42 Paracetamol (7)

    43 Pazopanib Hydrochloride (1)

    44 Penicillamine (1)

    45 Pirfenidone (1)

    46 Prazosin Hydrochloride (1)

    47 Rifaximin (2)

    48 Sorafenib (1)

    49 Telmisartan (1)

    50 Teneligliptin (2)

    51 Tenofovir Disoproxil Succinate (1)

    52 Tizanidine HCl (1)

    53 Trazodone Hydrochloride (2)

    54 Valsartan (1)

    55 Vigabatrin (1)

    56 Blank (4)

    filter

    01 Active (43)

    02 Inactive (14)

    03 Blank (26)

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    01 Valid (20)

    02 Withdrawn by Holder (7)

    03 Blank (56)

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    01 228MF10061 (1)

    02 305MF10066 (1)

    03 Blank (81)

    filter

    01 WC-0024 (26)

    02 WC-0024-A2 (1)

    03 WC-0024A3 (1)

    04 WC-0024A4 (1)

    05 WC-0024A5 (5)

    06 WC-0028 (3)

    07 WC-0116 (2)

    08 WC-0526 (3)

    09 Blank (41)

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    • FDA
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    Metformin

    PDF Supplier PDF
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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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    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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    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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    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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    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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    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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    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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    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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    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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    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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