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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Divis Laboratories Ltd

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    01 Alexidine Dihydrochloride (1)

    02 Apixaban (1)

    03 Benserazide Hydrochloride (1)

    04 Bosentan Hydrate (1)

    05 Brivaracetam (1)

    06 Bupropion Hydrobromide (1)

    07 Bupropion Hydrochloride (1)

    08 Capecitabine (1)

    09 Carbamazepine (1)

    10 Carbidopa (1)

    11 Carvedilol (2)

    12 Dabigatran Etexilate Mesylate (1)

    13 Desloratadine (1)

    14 Dextromethorphan (1)

    15 Dextromethorphan Hydrobromide (1)

    16 Diltiazem Hydrochloride (1)

    17 Entacapone (1)

    18 Ethanol (1)

    19 Etilevodopa (1)

    20 Fosphenytoin Sodium (1)

    21 Gabapentin (2)

    22 Gadolinium Dtpa (1)

    23 Gadoterate Meglumine (1)

    24 Iobitridol (1)

    25 Iodixanol (1)

    26 Iohexol (1)

    27 Iopamidol (1)

    28 Iopromide (2)

    29 Ioversol (1)

    30 Irbesartan (1)

    31 Ketorolac Trometamol (1)

    32 Lacosamide (1)

    33 Lamotrigine (1)

    34 Levetiracetam (2)

    35 Loratadine (1)

    36 Losartan Potassium (1)

    37 Mesalazine (1)

    38 Methyldopa (1)

    39 Mirabegron (1)

    40 Molnupiravir (1)

    41 Nabumetone (1)

    42 Naproxen (2)

    43 Naproxen Sodium (2)

    44 Niacin (1)

    45 Nirmatrelvir (1)

    46 Olmesartan Medoxomil (1)

    47 Orlistat (1)

    48 Phenprocoumon (1)

    49 Phenylephrine Hydrochloride (1)

    50 Phenytoin Sodium (1)

    51 Pregabalin (2)

    52 Proguanil (1)

    53 Quetiapine Hemifumarate (2)

    54 Raltegravir Potassium (1)

    55 Risedronate Sodium (1)

    56 Rivaroxaban (1)

    57 Sibutramine Hydrochloride (1)

    58 Simvastatin (1)

    59 Sitagliptin Phosphate (1)

    60 Succinate (1)

    61 Sulfasalazine (1)

    62 Sumatriptan (2)

    63 Tamsulosin (1)

    64 Telmisartan (1)

    65 Ticagrelor (1)

    66 Topiramate (1)

    67 Tripeptide (1)

    68 Triprolidine Hcl (1)

    69 Triprolidine Hydrochloride (1)

    70 Valacyclovir Hydrochloride (1)

    71 Valsartan (2)

    72 Venlafaxine Hydrochloride (1)

    73 Verapamil Hydrochloride (1)

    74 Vigabatrin (2)

    75 Vildagliptin (1)

    76 Zolpidem Tartrate (1)

    77 Blank (5)

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    01 Active (42)

    02 Inactive (14)

    03 Blank (36)

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    01 Valid (23)

    02 Withdrawn by Holder (2)

    03 Blank (67)

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    01 217MF10567 (1)

    02 220MF10194 (1)

    03 224MF10172 (1)

    04 224MF10232 (1)

    05 225MF10125 (1)

    06 227MF10235 (1)

    07 228MF10204 (1)

    08 231MF10004 (1)

    09 302MF10044 (1)

    10 302MF10067 (1)

    11 Blank (82)

    filter

    01 WC-0030 (27)

    02 WC-0030A3 (1)

    03 WC-0031 (19)

    04 WC-0031A2 (2)

    05 WC-0031A3 (1)

    06 Blank (42)

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    Dextromethorphan Hydrobromide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12356
    Active
    DEXTROMETHORPHAN HYDROBROMIDE USP
    1997-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-103 - Rev 06
    Valid
    Dextromethorphan hydrobromide
    2018-07-20
    Japanese DMF

    Found JDMF

    217MF10567
    Japanese Pharmacopoeia dextromethor...
    2005-09-09
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Dextromethorphan HBr (BP/USPIPh.Eur...
    2022-06-16
    Application Number
    12356
    R1-CEP 1999-103 - Rev 06
    217MF10567
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE USP
    Dextromethorphan hydrobromide
    Japanese Pharmacopoeia dextromethor...
    Dextromethorphan HBr (BP/USPIPh.Eur...
    Issue/Submission Date
    1997-02-04
    2018-07-20
    2005-09-09
    2022-06-16
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    Levetiracetam

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    USDMF

    Found USDMF

    16894
    Active
    LEVETIRACETAM
    2003-10-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-079 - Rev 01
    Valid
    Levetiracetam, Process B
    2020-12-04
    Japanese DMF

    Found JDMF

    302MF10067
    Levetiracetam at 1-72/23(P)/DIVIS/3...
    2020-06-16
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Levetiracetam (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    16894
    R1-CEP 2014-079 - Rev 01
    302MF10067
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    LEVETIRACETAM
    Levetiracetam, Process B
    Levetiracetam at 1-72/23(P)/DIVIS/3...
    Levetiracetam (USP/Ph.Eur/BP)
    Issue/Submission Date
    2003-10-05
    2020-12-04
    2020-06-16
    2022-06-16
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    Nabumetone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15364
    Active
    NABUMETONE USP
    2001-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-055 - Rev 06
    Valid
    Nabumetone
    2018-08-23
    Japanese DMF

    Found JDMF

    228MF10204
    Nabumetone at 1-72/23(P)/DIVIS/303,...
    2016-10-31
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Nabumetone (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    15364
    R1-CEP 1999-055 - Rev 06
    228MF10204
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    NABUMETONE USP
    Nabumetone
    Nabumetone at 1-72/23(P)/DIVIS/303,...
    Nabumetone (USP/Ph.Eur/BP)
    Issue/Submission Date
    2001-04-02
    2018-08-23
    2016-10-31
    2022-06-16
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    Carbidopa

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17846
    Active
    CARBIDOPA USP
    2004-11-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-057 - Rev 05
    Valid
    Carbidopa
    2021-11-22
    Japanese DMF

    Found JDMF

    225MF10125
    Carbidopa at 1-72/23(P)/DIVIS/303, ...
    2013-07-02
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Carbidopa (IP/BP/USP/Ph. Eur)
    2019-06-17
    Application Number
    17846
    R1-CEP 2005-057 - Rev 05
    225MF10125
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    CARBIDOPA USP
    Carbidopa
    Carbidopa at 1-72/23(P)/DIVIS/303, ...
    Carbidopa (IP/BP/USP/Ph. Eur)
    Issue/Submission Date
    2004-11-20
    2021-11-22
    2013-07-02
    2019-06-17
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    Etilevodopa

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17874
    Active
    LEVODOPA USP
    2004-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-161 - Rev 04
    Valid
    Levodopa
    2018-01-25
    Japanese DMF

    Found JDMF

    227MF10235
    Levodopa at 1-72/23(P)/DIVIS/303, D...
    2015-09-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Levodopa (IP/BP/USP/Ph. Eur)
    2019-06-17
    Application Number
    17874
    R1-CEP 2005-161 - Rev 04
    227MF10235
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    LEVODOPA USP
    Levodopa
    Levodopa at 1-72/23(P)/DIVIS/303, D...
    Levodopa (IP/BP/USP/Ph. Eur)
    Issue/Submission Date
    2004-12-03
    2018-01-25
    2015-09-24
    2019-06-17
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    Mesalazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29998
    Active
    MESALAMINE USP
    2015-11-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-050 - Rev 01
    Valid
    Mesalazine
    2022-11-08
    Japanese DMF

    Found JDMF

    231MF10004
    Mesalazine at 1-72/23(P)/DIVIS/303,...
    2019-01-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Mesalamine (IP/USP/BP/Ph.Eur)
    2019-06-17
    Application Number
    29998
    R1-CEP 2016-050 - Rev 01
    231MF10004
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    MESALAMINE USP
    Mesalazine
    Mesalazine at 1-72/23(P)/DIVIS/303,...
    Mesalamine (IP/USP/BP/Ph.Eur)
    Issue/Submission Date
    2015-11-06
    2022-11-08
    2019-01-10
    2019-06-17
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    Valsartan

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    USDMF

    Found USDMF

    24797
    Active
    VALSARTAN USP
    2011-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-338 - Rev 01
    Valid
    Valsartan
    2020-05-25
    Japanese DMF

    Found JDMF

    302MF10044
    Valsartan at 1-72/23(P)/DIVIS/303, ...
    2020-04-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0030
    Expired
    Valsartan (USP/Ph. Eur/1P)
    2019-06-17
    Application Number
    24797
    R1-CEP 2012-338 - Rev 01
    302MF10044
    Indian CDSCO WC-0030
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan at 1-72/23(P)/DIVIS/303, ...
    Valsartan (USP/Ph. Eur/1P)
    Issue/Submission Date
    2011-03-29
    2020-05-25
    2020-04-14
    2019-06-17
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    Dextromethorphan

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    USDMF

    Found USDMF

    22469
    Active
    DEXTROMETHORPHAN BASE USP
    2009-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10194
    Dextromethorphan base at 1-72/23(P)...
    2008-08-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Dextromethorphan (USP)
    2022-06-16
    Application Number
    22469
    220MF10194
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-06-16
    Filing Details
    DEXTROMETHORPHAN BASE USP
    Dextromethorphan base at 1-72/23(P)...
    Dextromethorphan (USP)
    Issue/Submission Date
    2009-01-28
    2008-08-28
    2022-06-16
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    Diltiazem Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15267
    Active
    DILTIAZEM HYDROCHLORIDE USP
    2001-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-156 - Rev 10
    Valid
    Diltiazem hydrochloride
    2020-02-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Diltiazem Hydrochloride (BP/USP/Ph....
    2022-06-16
    Application Number
    15267
    R1-CEP 1999-156 - Rev 10
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    DILTIAZEM HYDROCHLORIDE USP
    Diltiazem hydrochloride
    Diltiazem Hydrochloride (BP/USP/Ph....
    Issue/Submission Date
    2001-01-26
    2020-02-24
    2022-06-16
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    Iopamidol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18066
    Active
    IOPAMIDOL USP
    2005-02-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-038 - Rev 04
    Valid
    Iopamidol
    2018-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0031
    Valid
    Iopamidol (USP/Ph.Eur/BP)
    2022-06-16
    Application Number
    18066
    R1-CEP 2006-038 - Rev 04
    Indian CDSCO WC-0031
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-16
    Filing Details
    IOPAMIDOL USP
    Iopamidol
    Iopamidol (USP/Ph.Eur/BP)
    Issue/Submission Date
    2005-02-06
    2018-12-10
    2022-06-16
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