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

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    Ipca Laboratories
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    India
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    Kandivli (West), Mumbai – 400 067, Maharashtra
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    Alendronate Sodium

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    USDMF

    Found USDMF

    21008
    Active
    ALENDRONATE SODIUM USP
    2007-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-090 - Rev 02
    Valid
    Sodium alendronate trihydrate
    2021-04-27
    Japanese DMF

    Found JDMF

    219MF10310
    Alendronate sodium hydrate at 48, K...
    2007-10-05
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Sodium Alendronate (BP/Ph.Eur)
    2022-06-08
    Application Number
    21008
    R1-CEP 2008-090 - Rev 02
    219MF10310
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ALENDRONATE SODIUM USP
    Sodium alendronate trihydrate
    Alendronate sodium hydrate at 48, K...
    Sodium Alendronate (BP/Ph.Eur)
    Issue/Submission Date
    2007-12-03
    2021-04-27
    2007-10-05
    2022-06-08
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    Furosemide

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    USDMF

    Found USDMF

    10109
    Active
    FUROSEMIDE USP
    1993-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-020 - Rev 07
    Valid
    Furosemide
    2019-10-30
    Japanese DMF

    Found JDMF

    225MF10191
    Furosemide at 48, Kandivli Industri...
    2013-10-09
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Furosemide ((BP/JP/ Ph.Eur)
    2022-06-08
    Application Number
    10109
    R1-CEP 1998-020 - Rev 07
    225MF10191
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FUROSEMIDE USP
    Furosemide
    Furosemide at 48, Kandivli Industri...
    Furosemide ((BP/JP/ Ph.Eur)
    Issue/Submission Date
    1993-02-23
    2019-10-30
    2013-10-09
    2022-06-08
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    Glimepiride

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    USDMF

    Found USDMF

    20037
    Active
    GLIMEPIRIDE USP
    2006-12-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-036 - Rev 01
    Valid
    Glimepiride
    2019-12-18
    Japanese DMF

    Found JDMF

    226MF10075
    Glimepiride (production only) at 48...
    2014-04-02
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Glimepiride (BP/USP/ Ph.Eur)
    2022-06-08
    Application Number
    20037
    R1-CEP 2007-036 - Rev 01
    226MF10075
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GLIMEPIRIDE USP
    Glimepiride
    Glimepiride (production only) at 48...
    Glimepiride (BP/USP/ Ph.Eur)
    Issue/Submission Date
    2006-12-19
    2019-12-18
    2014-04-02
    2022-06-08
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    16707
    Active
    HYDROCHLOROTHIAZIDE USP
    2003-07-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-013 - Rev 06
    Valid
    Hydrochlorothiazide, Process I
    2023-08-29
    Japanese DMF

    Found JDMF

    224MF10171
    Hydrochlorothiazide at 48, Kandivli...
    2012-08-16
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Hydrohlorothiazide (BP/USP/ Ph.Eur/...
    2022-06-08
    Application Number
    16707
    R1-CEP 2004-013 - Rev 06
    224MF10171
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide, Process I
    Hydrochlorothiazide at 48, Kandivli...
    Hydrohlorothiazide (BP/USP/ Ph.Eur/...
    Issue/Submission Date
    2003-07-07
    2023-08-29
    2012-08-16
    2022-06-08
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    Metoprolol Tartrate

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    USDMF

    Found USDMF

    15850
    Active
    METOPROLOL TARTRATE USP
    2002-02-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-091 - Rev 04
    Valid
    Metoprolol tartrate
    2023-03-16
    Japanese DMF

    Found JDMF

    221MF10151
    Metoprolol tartrate at 48, Kandivli...
    2009-07-09
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Metoprolol Tartrate (BP/USP/ Ph.Eur...
    2022-06-08
    Application Number
    15850
    R1-CEP 2003-091 - Rev 04
    221MF10151
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METOPROLOL TARTRATE USP
    Metoprolol tartrate
    Metoprolol tartrate at 48, Kandivli...
    Metoprolol Tartrate (BP/USP/ Ph.Eur...
    Issue/Submission Date
    2002-02-02
    2023-03-16
    2009-07-09
    2022-06-08
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    Propranolol Hydrochloride

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    USDMF

    Found USDMF

    15849
    Active
    PROPRANOLOL HYDROCHLORIDE USP
    2002-02-01
    CEP/COS

    Found CEP/COS

    CEP 2002-026 - Rev 06
    Valid
    Propranolol hydrochloride
    2023-12-06
    Japanese DMF

    Found JDMF

    218MF10174
    Propranolol hydrochloride at 48, Ka...
    2006-02-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Propanolol Hydrochloride (BP/USP/ P...
    2022-06-08
    Application Number
    15849
    CEP 2002-026 - Rev 06
    218MF10174
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PROPRANOLOL HYDROCHLORIDE USP
    Propranolol hydrochloride
    Propranolol hydrochloride at 48, Ka...
    Propanolol Hydrochloride (BP/USP/ P...
    Issue/Submission Date
    2002-02-01
    2023-12-06
    2006-02-08
    2022-06-08
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    Atenolol

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    USDMF

    Caution USDMF

    7821
    Inactive
    ATENOLOL
    1988-12-15
    CEP/COS

    Found CEP/COS

    CEP 1998-024 - Rev 06
    Valid
    Atenolol
    2023-11-10
    Japanese DMF

    Found JDMF

    218MF10439
    Atenolol at 48, Kandivli Industrial...
    2006-04-27
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Atenolol (BP/JPC/USP/Ph. Eur)
    2022-06-08
    Application Number
    7821
    CEP 1998-024 - Rev 06
    218MF10439
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ATENOLOL
    Atenolol
    Atenolol at 48, Kandivli Industrial...
    Atenolol (BP/JPC/USP/Ph. Eur)
    Issue/Submission Date
    1988-12-15
    2023-11-10
    2006-04-27
    2022-06-08
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    Losartan Potassium

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    USDMF

    Caution USDMF

    16526
    Inactive
    LOSARTAN POTASSIUM
    2003-04-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-224 - Rev 03
    Valid
    Losartan potassium, LB4 Process
    2023-01-12
    Japanese DMF

    Found JDMF

    222MF10266
    Losartan potassium at 48, Kandivli ...
    2010-12-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Losartan Potassium (BP/ Ph.Eur)
    2022-06-08
    Application Number
    16526
    R0-CEP 2019-224 - Rev 03
    222MF10266
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LOSARTAN POTASSIUM
    Losartan potassium, LB4 Process
    Losartan potassium at 48, Kandivli ...
    Losartan Potassium (BP/ Ph.Eur)
    Issue/Submission Date
    2003-04-05
    2023-01-12
    2010-12-08
    2022-06-08
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    Allopurinol

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    USDMF

    Found USDMF

    21676
    Active
    ALLOPURINOL USP
    2008-07-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-211 - Rev 04
    Valid
    Allopurinol
    2023-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Allopurinol (USP/BP/Ph.Eur.)
    2022-06-08
    Application Number
    21676
    R1-CEP 2008-211 - Rev 04
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ALLOPURINOL USP
    Allopurinol
    Allopurinol (USP/BP/Ph.Eur.)
    Issue/Submission Date
    2008-07-25
    2023-01-27
    2022-06-08
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    23589
    Active
    AMLODIPINE BESYLATE USP
    2010-07-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-237 - Rev 01
    Valid
    Amlodipine besilate
    2018-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Amlodipine Besylate (BP/Ph. Eur./US...
    2022-06-08
    Application Number
    23589
    R1-CEP 2010-237 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    AMLODIPINE BESYLATE USP
    Amlodipine besilate
    Amlodipine Besylate (BP/Ph. Eur./US...
    Issue/Submission Date
    2010-07-30
    2018-11-07
    2022-06-08
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    Carvedilol

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    USDMF

    Found USDMF

    20930
    Active
    CARVEDILOL USP
    2007-10-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-298 - Rev 01
    Valid
    Carvedilol
    2019-06-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Carvedilol (BP/USP/Ph. Eur)
    2022-06-08
    Application Number
    20930
    R1-CEP 2007-298 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CARVEDILOL USP
    Carvedilol
    Carvedilol (BP/USP/Ph. Eur)
    Issue/Submission Date
    2007-10-18
    2019-06-25
    2022-06-08
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    20997
    Active
    CETIRIZINE HYDROCHLORIDE USP
    2007-11-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-309 - Rev 01
    Valid
    Cetirizine dihydrochloride
    2017-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Cetirizine Dihydrochloride (BP/Ph.E...
    2022-06-08
    Application Number
    20997
    R1-CEP 2006-309 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CETIRIZINE HYDROCHLORIDE USP
    Cetirizine dihydrochloride
    Cetirizine Dihydrochloride (BP/Ph.E...
    Issue/Submission Date
    2007-11-30
    2017-08-03
    2022-06-08
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    Chloroquine Phosphate

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    USDMF

    Found USDMF

    9235
    Active
    CHLOROQUINE PHOSPHATE USP
    1991-07-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-177 - Rev 01
    Valid
    Chloroquine Phosphate
    2021-08-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Chloroquine Phosphate (BP/ Ph.Eur/U...
    2022-06-08
    Application Number
    9235
    R1-CEP 2005-177 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CHLOROQUINE PHOSPHATE USP
    Chloroquine Phosphate
    Chloroquine Phosphate (BP/ Ph.Eur/U...
    Issue/Submission Date
    1991-07-02
    2021-08-05
    2022-06-08
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    Chlorthalidone

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    USDMF

    Found USDMF

    17808
    Active
    CHLORTHALIDONE USP
    2004-11-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-004 - Rev 00
    Valid
    Chlortalidone
    2013-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Chlorthalidone/Chlortalidone (BP/ P...
    2022-06-08
    Application Number
    17808
    R1-CEP 2006-004 - Rev 00
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CHLORTHALIDONE USP
    Chlortalidone
    Chlorthalidone/Chlortalidone (BP/ P...
    Issue/Submission Date
    2004-11-03
    2013-04-19
    2022-06-08
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    Famotidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-062 - Rev 04
    Valid
    Famotidine
    2013-05-06
    Japanese DMF

    Found JDMF

    218MF10736
    FAMOTIDINE JP at 48, Kandivli Indus...
    2006-09-06
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Famotidine (Ph. Eur)
    2022-06-08
    Application Number
    R1-CEP 2000-062 - Rev 04
    218MF10736
    Indian CDSCO WC-0091
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Famotidine
    FAMOTIDINE JP at 48, Kandivli Indus...
    Famotidine (Ph. Eur)
    Issue/Submission Date
    2013-05-06
    2006-09-06
    2022-06-08
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    Hydroxychloroquine Sulphate

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    USDMF

    Found USDMF

    14087
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    1999-04-17
    CEP/COS

    Found CEP/COS

    CEP 2018-196 - Rev 02
    Valid
    Hydroxychloroquine sulfate
    2023-10-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Hydroxy Chloroquine Sulphate (BP/US...
    2022-06-08
    Application Number
    14087
    CEP 2018-196 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Hydroxychloroquine sulfate
    Hydroxy Chloroquine Sulphate (BP/US...
    Issue/Submission Date
    1999-04-17
    2023-10-24
    2022-06-08
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    Hydroxyzine Dihydrochloride

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    USDMF

    Found USDMF

    23283
    Active
    HYDROXYZINE HYDROCHLORIDE USP
    2010-04-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-076 - Rev 02
    Valid
    Hydroxyzine hydrochloride
    2021-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Hydroxyzine Di Hydrochloride (BP/US...
    2022-06-08
    Application Number
    23283
    R1-CEP 2010-076 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    HYDROXYZINE HYDROCHLORIDE USP
    Hydroxyzine hydrochloride
    Hydroxyzine Di Hydrochloride (BP/US...
    Issue/Submission Date
    2010-04-09
    2021-08-03
    2022-06-08
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    Indapamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21975
    Active
    INDAPAMIDE USP
    2008-10-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-268 - Rev 00
    Valid
    Indapamide
    2015-04-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Indapamide (BP/USP/ Ph.Eur/CP)
    2022-06-08
    Application Number
    21975
    R1-CEP 2008-268 - Rev 00
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    INDAPAMIDE USP
    Indapamide
    Indapamide (BP/USP/ Ph.Eur/CP)
    Issue/Submission Date
    2008-10-06
    2015-04-13
    2022-06-08
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    Metformin

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    USDMF

    Found USDMF

    18323
    Active
    METFORMIN HYDROCHLORIDE USP
    2005-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-156 - Rev 04
    Valid
    Metformin Hydrochloride
    2022-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Metformin Hydrochloride (BP/USP/ Ph...
    2022-06-08
    Application Number
    18323
    R1-CEP 2005-156 - Rev 04
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METFORMIN HYDROCHLORIDE USP
    Metformin Hydrochloride
    Metformin Hydrochloride (BP/USP/ Ph...
    Issue/Submission Date
    2005-05-26
    2022-12-19
    2022-06-08
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    Metoclopramide Hydrochloride

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    USDMF

    Found USDMF

    7581
    Active
    METOCLOPRAMIDE HCL USP
    1988-07-15
    CEP/COS

    Found CEP/COS

    CEP 2004-075 - Rev 05
    Valid
    Metoclopramide Hydrochloride monohy...
    2024-03-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Metoclopramide Hydrochloride (BP/US...
    2022-06-08
    Application Number
    7581
    CEP 2004-075 - Rev 05
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METOCLOPRAMIDE HCL USP
    Metoclopramide Hydrochloride monohy...
    Metoclopramide Hydrochloride (BP/US...
    Issue/Submission Date
    1988-07-15
    2024-03-12
    2022-06-08
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    Nifedipine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-102 - Rev 01
    Valid
    Nifedipine
    2023-02-20
    Japanese DMF

    Found JDMF

    227MF10111
    Nifedipine at 48, Kandivli Industri...
    2015-04-21
    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Nifedipine (Ph. Eur)
    2022-06-08
    Application Number
    R1-CEP 2014-102 - Rev 01
    227MF10111
    Indian CDSCO WC-0091
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Nifedipine
    Nifedipine at 48, Kandivli Industri...
    Nifedipine (Ph. Eur)
    Issue/Submission Date
    2023-02-20
    2015-04-21
    2022-06-08
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    20771
    Active
    ONDANSETRON HYDROCHLORIDE USP
    2007-08-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-237 - Rev 02
    Valid
    Ondansetron hydrochloride dihydrate
    2019-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Ondansetron Hydrochloride Dihydrate...
    2022-06-08
    Application Number
    20771
    R1-CEP 2007-237 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ONDANSETRON HYDROCHLORIDE USP
    Ondansetron hydrochloride dihydrate
    Ondansetron Hydrochloride Dihydrate...
    Issue/Submission Date
    2007-08-20
    2019-09-18
    2022-06-08
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    Primaquine Diphosphate

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    USDMF

    Found USDMF

    25258
    Active
    PRIMAQUINE PHOSPHATE USP
    2011-10-11
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-258 - Rev 00
    Valid
    Primaquine diphosphate, PQ3 Process
    2023-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Primaquine Phosphate (BP/USP/ Ph.Eu...
    2022-06-08
    Application Number
    25258
    R0-CEP 2022-258 - Rev 00
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PRIMAQUINE PHOSPHATE USP
    Primaquine diphosphate, PQ3 Process
    Primaquine Phosphate (BP/USP/ Ph.Eu...
    Issue/Submission Date
    2011-10-11
    2023-06-23
    2022-06-08
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    Proguanil

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    USDMF

    Found USDMF

    21475
    Active
    PROGUANIL HYDROCHLORIDE USP
    2008-06-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-180 - Rev 03
    Valid
    Proguanil hydrochloride
    2021-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Proguanil Hydrochloride (BP/Ph.Eur)
    2022-06-08
    Application Number
    21475
    R1-CEP 2008-180 - Rev 03
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PROGUANIL HYDROCHLORIDE USP
    Proguanil hydrochloride
    Proguanil Hydrochloride (BP/Ph.Eur)
    Issue/Submission Date
    2008-06-16
    2021-12-06
    2022-06-08
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    Pyrantel Pamoate

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    USDMF

    Found USDMF

    7822
    Active
    PYRANTEL PAMOATE USP
    1988-12-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-294 - Rev 02
    Valid
    Pyrantel embonate
    2020-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Pyantel Embonate (BP/Ph.Eur)
    2022-06-08
    Application Number
    7822
    R1-CEP 2005-294 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PYRANTEL PAMOATE USP
    Pyrantel embonate
    Pyantel Embonate (BP/Ph.Eur)
    Issue/Submission Date
    1988-12-15
    2020-12-14
    2022-06-08
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    Pyrimethamine

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    USDMF

    Found USDMF

    22880
    Active
    PYRIMETHAMINE USP
    2009-06-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-183 - Rev 02
    Valid
    Pyrimethamine
    2019-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Pyrimethamine (BP/USP/ Ph.Eur)
    2022-06-08
    Application Number
    22880
    R1-CEP 2009-183 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PYRIMETHAMINE USP
    Pyrimethamine
    Pyrimethamine (BP/USP/ Ph.Eur)
    Issue/Submission Date
    2009-06-26
    2019-03-28
    2022-06-08
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    21009
    Active
    QUETIAPINE HEMIFUMARATE
    2007-12-14
    CEP/COS

    Found CEP/COS

    CEP 2018-163 - Rev 01
    Valid
    Quetiapine Fumarate
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Quetiapine Hemifumarate (IH)
    2022-06-08
    Application Number
    21009
    CEP 2018-163 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    QUETIAPINE HEMIFUMARATE
    Quetiapine Fumarate
    Quetiapine Hemifumarate (IH)
    Issue/Submission Date
    2007-12-14
    2023-11-29
    2022-06-08
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    Telmisartan

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    USDMF

    Found USDMF

    27946
    Active
    TELMISARTAN USP
    2014-03-12
    CEP/COS

    Found CEP/COS

    CEP 2020-211 - Rev 02
    Valid
    Telmisartan
    2023-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Telmisartan (BP/USP/ Ph.Eur/IP)
    2022-06-08
    Application Number
    27946
    CEP 2020-211 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TELMISARTAN USP
    Telmisartan
    Telmisartan (BP/USP/ Ph.Eur/IP)
    Issue/Submission Date
    2014-03-12
    2023-12-20
    2022-06-08
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    Torsemide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23760
    Active
    TORSEMIDE USP
    2010-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-278 - Rev 01
    Valid
    Torasemide
    2023-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Torsemide (USP/ Ph.Eur)
    2022-06-08
    Application Number
    23760
    R1-CEP 2010-278 - Rev 01
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TORSEMIDE USP
    Torasemide
    Torsemide (USP/ Ph.Eur)
    Issue/Submission Date
    2010-09-15
    2023-07-11
    2022-06-08
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    Trimethoprim

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    URL Supplier Web Content
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    USDMF

    Found USDMF

    8545
    Active
    TRIMETHOPRIM USP
    1990-02-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-104 - Rev 06
    Valid
    Trimethoprim
    2017-02-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Trimethoprim (BP/USP/ Ph.Eur/JPC)
    2022-06-08
    Application Number
    8545
    R1-CEP 1999-104 - Rev 06
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TRIMETHOPRIM USP
    Trimethoprim
    Trimethoprim (BP/USP/ Ph.Eur/JPC)
    Issue/Submission Date
    1990-02-21
    2017-02-21
    2022-06-08
    ASK
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    • FDA
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    Venlafaxine Hydrochloride

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    URL Supplier Web Content
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    USDMF

    Found USDMF

    31497
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2017-07-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-161 - Rev 00
    Valid
    Venlafaxine hydrochloride
    2023-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Venlafaxine Hydrochloride (USP/ Ph....
    2022-06-08
    Application Number
    31497
    R1-CEP 2017-161 - Rev 00
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride
    Venlafaxine Hydrochloride (USP/ Ph....
    Issue/Submission Date
    2017-07-03
    2023-07-28
    2022-06-08
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    Warfarin Sodium

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    USDMF

    Found USDMF

    21680
    Active
    WARFARIN SODIUM CLATHRATE USP
    2008-08-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-041 - Rev 02
    Valid
    Warfarin sodium
    2019-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Warfarin Sodium (USP/EP)
    2022-06-08
    Application Number
    21680
    R1-CEP 2009-041 - Rev 02
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    WARFARIN SODIUM CLATHRATE USP
    Warfarin sodium
    Warfarin Sodium (USP/EP)
    Issue/Submission Date
    2008-08-12
    2019-06-17
    2022-06-08
    ASK
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    Bendroflumethiazide

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    USDMF

    Caution USDMF

    19857
    Inactive
    BENDROFLUMETHIAZIDE USP
    2006-11-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-142 - Rev 03
    Valid
    Bendroflumethiazide
    2018-04-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Bendroflumethiazide (BP/ Ph. Eur)
    2022-06-08
    Application Number
    19857
    R1-CEP 2007-142 - Rev 03
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    BENDROFLUMETHIAZIDE USP
    Bendroflumethiazide
    Bendroflumethiazide (BP/ Ph. Eur)
    Issue/Submission Date
    2006-11-07
    2018-04-23
    2022-06-08
    ASK
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    Bisoprolol Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    24120
    Inactive
    BISOPROLOL FUMARATE USP
    2010-12-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-366 - Rev 00
    Valid
    Bisoprolol fumarate
    2022-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Bisoprolol Fumarate (Ph.Eur/USP)
    2022-06-08
    Application Number
    24120
    R1-CEP 2015-366 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    BISOPROLOL FUMARATE USP
    Bisoprolol fumarate
    Bisoprolol Fumarate (Ph.Eur/USP)
    Issue/Submission Date
    2010-12-09
    2022-01-17
    2022-06-08
    ASK
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    your Marketing & Sales content
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    • FDA
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    Citalopram Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    24121
    Inactive
    CITALOPRAM HYDROBROMIDE USP
    2010-12-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-296 - Rev 00
    Valid
    Citalopram hydrobromide
    2016-12-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Citalopram Hydrobromide (BP/USP/ Ph...
    2022-06-08
    Application Number
    24121
    R1-CEP 2010-296 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CITALOPRAM HYDROBROMIDE USP
    Citalopram hydrobromide
    Citalopram Hydrobromide (BP/USP/ Ph...
    Issue/Submission Date
    2010-12-15
    2016-12-08
    2022-06-08
    ASK
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    • FDA
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    Etodolac

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21449
    Inactive
    ETODOLAC
    2008-04-16
    CEP/COS

    Found CEP/COS

    CEP 2008-175 - Rev 04
    Valid
    Etodolac
    2023-09-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Etodolac (BP/USP/ Ph.Eur)
    2022-06-08
    Application Number
    21449
    CEP 2008-175 - Rev 04
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ETODOLAC
    Etodolac
    Etodolac (BP/USP/ Ph.Eur)
    Issue/Submission Date
    2008-04-16
    2023-09-21
    2022-06-08
    ASK
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    your Marketing & Sales content
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    • FDA
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    Fenofibrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21677
    Inactive
    FENOFIBRATE USP
    2008-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-253 - Rev 00
    Valid
    Fenofibrate
    2014-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Fenofibrate (BP/USP/ Ph.Eur)
    2022-06-08
    Application Number
    21677
    R1-CEP 2008-253 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FENOFIBRATE USP
    Fenofibrate
    Fenofibrate (BP/USP/ Ph.Eur)
    Issue/Submission Date
    2008-09-20
    2014-11-27
    2022-06-08
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    Fluconazole

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    USDMF

    Caution USDMF

    20929
    Inactive
    FLUCONAZOLE USP
    2007-10-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-308 - Rev 00
    Valid
    Fluconazole
    2014-12-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Fluconazole (BP/USP/ Ph.Eur/CP)
    2022-06-08
    Application Number
    20929
    R1-CEP 2007-308 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUCONAZOLE USP
    Fluconazole
    Fluconazole (BP/USP/ Ph.Eur/CP)
    Issue/Submission Date
    2007-10-22
    2014-12-02
    2022-06-08
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    Flumequine

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    USDMF

    Caution USDMF

    10709
    Inactive
    FLUMEQUINE
    1994-02-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-318 - Rev 04
    Valid
    Flumequine
    2020-07-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Flumequine ((BP/Ph.Eur)
    2022-06-08
    Application Number
    10709
    R1-CEP 2001-318 - Rev 04
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUMEQUINE
    Flumequine
    Flumequine ((BP/Ph.Eur)
    Issue/Submission Date
    1994-02-02
    2020-07-16
    2022-06-08
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    Losartan Potassium

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    USDMF

    Found USDMF

    17460
    Active
    LOSARTAN POTASSIUM USP (PROCESS II)
    2004-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-190 - Rev 05
    Valid
    Losartan potassium, LB7 Process
    2022-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0464
    Expired
    Losartan Potassium USP/BP/EP
    2020-03-02
    Application Number
    17460
    R1-CEP 2009-190 - Rev 05
    Indian CDSCO WC-0464
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-03-02
    Filing Details
    LOSARTAN POTASSIUM USP (PROCESS II)
    Losartan potassium, LB7 Process
    Losartan Potassium USP/BP/EP
    Issue/Submission Date
    2004-06-10
    2022-08-04
    2020-03-02
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    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19261
    Inactive
    MESALAMINE USP
    2006-04-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-122 - Rev 04
    Valid
    Mesalazine
    2019-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Mesalamine/Mesalazine (BP/USP/ Ph.E...
    2022-06-08
    Application Number
    19261
    R1-CEP 2006-122 - Rev 04
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MESALAMINE USP
    Mesalazine
    Mesalamine/Mesalazine (BP/USP/ Ph.E...
    Issue/Submission Date
    2006-04-18
    2019-12-05
    2022-06-08
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    Methylphenidate Hydrochloride

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    USDMF

    Caution USDMF

    20621
    Inactive
    METHYLPHENIDATE HYDROCHLORIDE USP
    2007-07-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-094 - Rev 00
    Valid
    Methylphenidate hydrochloride
    2015-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Methyl phenidate Hydrochloride (BP/...
    2022-06-08
    Application Number
    20621
    R1-CEP 2009-094 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE USP
    Methylphenidate hydrochloride
    Methyl phenidate Hydrochloride (BP/...
    Issue/Submission Date
    2007-07-05
    2015-08-03
    2022-06-08
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    Metoprolol Succinate

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    USDMF

    Caution USDMF

    17056
    Inactive
    METOPROLOL SUCCINATE
    2003-12-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-028 - Rev 04
    Valid
    Metoprolol succinate
    2023-04-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Metoprolol Succinate (BP/USP/ Ph.Eu...
    2022-06-08
    Application Number
    17056
    R1-CEP 2004-028 - Rev 04
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METOPROLOL SUCCINATE
    Metoprolol succinate
    Metoprolol Succinate (BP/USP/ Ph.Eu...
    Issue/Submission Date
    2003-12-22
    2023-04-11
    2022-06-08
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    Nabumetone

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    USDMF

    Caution USDMF

    17566
    Inactive
    NABUMETONE
    2004-07-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-078 - Rev 02
    Valid
    Nabumetone
    2017-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Nabumetone (BP/USP/ Ph.Eur)
    2022-06-08
    Application Number
    17566
    R1-CEP 2004-078 - Rev 02
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    NABUMETONE
    Nabumetone
    Nabumetone (BP/USP/ Ph.Eur)
    Issue/Submission Date
    2004-07-19
    2017-02-23
    2022-06-08
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    Paroxetine Hydrochloride

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    USDMF

    Caution USDMF

    21007
    Inactive
    PAROXETINE HYDROCHLORIDE
    2008-04-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-095 - Rev 00
    Valid
    Paroxetine hydrochloride hemihydrat...
    2021-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Paroxetine HCL Hemihydrate(BP/ Ph.E...
    2022-06-08
    Application Number
    21007
    R1-CEP 2014-095 - Rev 00
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PAROXETINE HYDROCHLORIDE
    Paroxetine hydrochloride hemihydrat...
    Paroxetine HCL Hemihydrate(BP/ Ph.E...
    Issue/Submission Date
    2008-04-17
    2021-01-11
    2022-06-08
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    Valsartan

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    USDMF

    Caution USDMF

    22614
    Inactive
    VALSARTAN USP
    2010-04-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-100 - Rev 05
    Valid
    Valsartan
    2022-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Valsartan (BP/USP/ Ph.Eur/IP)
    2022-06-08
    Application Number
    22614
    R1-CEP 2010-100 - Rev 05
    Indian CDSCO WC-0091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan (BP/USP/ Ph.Eur/IP)
    Issue/Submission Date
    2010-04-01
    2022-11-18
    2022-06-08
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    18563
    Active
    HYDROCHLOROTHIAZIDE USP, PROCESS II
    2005-11-11
    CEP/COS

    Found CEP/COS

    CEP 2012-044 - Rev 02
    Valid
    Hydrochlorothiazide, Process III
    2023-09-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18563
    CEP 2012-044 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCHLOROTHIAZIDE USP, PROCESS II
    Hydrochlorothiazide, Process III
    Issue/Submission Date
    2005-11-11
    2023-09-26
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    Mesalazine

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    USDMF

    Found USDMF

    22617
    Active
    MESALAMINE USP (PROCESS II)
    2010-04-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-381 - Rev 00
    Valid
    Mesalazine, Mesalazine (MZ4B Proces...
    2021-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22617
    R0-CEP 2020-381 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP (PROCESS II)
    Mesalazine, Mesalazine (MZ4B Proces...
    Issue/Submission Date
    2010-04-03
    2021-03-15
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    Risperidone

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    USDMF

    Found USDMF

    22911
    Active
    RISPERIDONE USP
    2009-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0091
    Valid
    Risperidone (Ph. Eur)
    2022-06-08
    Application Number
    22911
    Indian CDSCO WC-0091
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    RISPERIDONE USP
    Risperidone (Ph. Eur)
    Issue/Submission Date
    2009-07-15
    2022-06-08
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    21679
    Active
    TRAMADOL HYDROCHLORIDE USP
    2008-07-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-085 - Rev 00
    Valid
    Tramadol hydrochloride, YT3 process
    2016-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21679
    R1-CEP 2011-085 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TRAMADOL HYDROCHLORIDE USP
    Tramadol hydrochloride, YT3 process
    Issue/Submission Date
    2008-07-01
    2016-08-04
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