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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sun Pharmaceutical Industries Limited

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    Sun Pharmaceutical Industries Limited
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063
    Telephone
    Telephone
    +91-22-4324 4324, +91 22 6696 9696
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://sunpharma.com/
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    Linkedin
    https://in.linkedin.com/company/sun-pharma
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    Gemcitabine

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    USDMF

    Found USDMF

    19427
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2006-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-021 - Rev 01
    Valid
    Gemcitabine hydrochloride
    2015-07-28
    Japanese DMF

    Found JDMF

    221MF10018
    GEMCITABINE HYDROCHLORIDE at SUN HO...
    2009-01-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Gemcitabine Hydrochloride (USP/EP/B...
    2022-06-08
    Application Number
    19427
    R1-CEP 2007-021 - Rev 01
    221MF10018
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride
    GEMCITABINE HYDROCHLORIDE at SUN HO...
    Gemcitabine Hydrochloride (USP/EP/B...
    Issue/Submission Date
    2006-05-16
    2015-07-28
    2009-01-28
    2022-06-08
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    16002
    Active
    TRAMADOL HYDROCHLORIDE USP
    2002-06-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-141 - Rev 01
    Valid
    Tramadol hydrochloride, Process-II
    2021-03-31
    Japanese DMF

    Found JDMF

    226MF10018
    Tramadol Hydrochloride at SUN HOUSE...
    2014-01-21
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Tramadol Hydrochloride (EP/USP)
    2022-06-08
    Application Number
    16002
    R0-CEP 2020-141 - Rev 01
    226MF10018
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    TRAMADOL HYDROCHLORIDE USP
    Tramadol hydrochloride, Process-II
    Tramadol Hydrochloride at SUN HOUSE...
    Tramadol Hydrochloride (EP/USP)
    Issue/Submission Date
    2002-06-06
    2021-03-31
    2014-01-21
    2022-06-08
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    • FDA
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    Mesalazine

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    USDMF

    Caution USDMF

    16431
    Inactive
    MESALAMINE USP (5-AMINO SALICYLIC A...
    2003-02-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-246 - Rev 00
    Valid
    Mesalazine, Site II
    2022-04-08
    Japanese DMF

    Found JDMF

    219MF10100
    Mesalazine (production only) at SUN...
    2007-03-14
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Mesalamine/Mesalazine (USP/EP/BP)
    2022-06-08
    Application Number
    16431
    R1-CEP 2016-246 - Rev 00
    219MF10100
    Indian CDSCO WC-0159
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    MESALAMINE USP (5-AMINO SALICYLIC A...
    Mesalazine, Site II
    Mesalazine (production only) at SUN...
    Mesalamine/Mesalazine (USP/EP/BP)
    Issue/Submission Date
    2003-02-17
    2022-04-08
    2007-03-14
    2022-06-08
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    • FDA
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    Bicalutamide

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    USDMF

    Found USDMF

    20263
    Active
    BICALUTAMIDE USP
    2007-02-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10195
    Bicalutamide at SUN HOUSE, Plot No....
    2014-10-27
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Bicalutamide (USP)
    2022-06-08
    Application Number
    20263
    226MF10195
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide at SUN HOUSE, Plot No....
    Bicalutamide (USP)
    Issue/Submission Date
    2007-02-10
    2014-10-27
    2022-06-08
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    Capecitabine

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    USDMF

    Found USDMF

    26018
    Active
    CAPECITABINE USP
    2012-07-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-140 - Rev 00
    Valid
    Capecitabine
    2022-09-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Capecitabine (USP)
    2022-06-08
    Application Number
    26018
    R1-CEP 2016-140 - Rev 00
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    CAPECITABINE USP
    Capecitabine
    Capecitabine (USP)
    Issue/Submission Date
    2012-07-13
    2022-09-08
    2022-06-08
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    Carboplatin

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    USDMF

    Found USDMF

    16664
    Active
    CARBOPLATIN USP
    2003-06-20
    CEP/COS

    Found CEP/COS

    CEP 2003-155 - Rev 03
    Valid
    Carboplatin
    2023-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Carboplatin (USP/EP/BP)
    2022-06-08
    Application Number
    16664
    CEP 2003-155 - Rev 03
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    CARBOPLATIN USP
    Carboplatin
    Carboplatin (USP/EP/BP)
    Issue/Submission Date
    2003-06-20
    2023-12-14
    2022-06-08
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    Desloratadine

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    USDMF

    Found USDMF

    19014
    Active
    DESLORATADINE
    2005-12-08
    CEP/COS

    Found CEP/COS

    CEP 2013-231 - Rev 02
    Valid
    Desloratadine
    2023-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Desloratadine (IH)
    2022-06-08
    Application Number
    19014
    CEP 2013-231 - Rev 02
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    DESLORATADINE
    Desloratadine
    Desloratadine (IH)
    Issue/Submission Date
    2005-12-08
    2023-11-20
    2022-06-08
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    Divalproex Sodium

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    USDMF

    Found USDMF

    19884
    Active
    DIVALPROEX SODIUM USP
    2006-10-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-140 - Rev 01
    Valid
    Valproic acid, Process II
    2022-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Divalproex Sodium (USP)/Valporic Ac...
    2022-06-08
    Application Number
    19884
    R1-CEP 2014-140 - Rev 01
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-25
    Filing Details
    DIVALPROEX SODIUM USP
    Valproic acid, Process II
    Divalproex Sodium (USP)/Valporic Ac...
    Issue/Submission Date
    2006-10-14
    2022-06-24
    2022-06-08
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    Fluvoxamine

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    USDMF

    Found USDMF

    16174
    Active
    FLUVOXAMINE MALEATE USP
    2002-09-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10042
    FLUVOXAMINE MALEATE at SUN HOUSE, P...
    2009-02-23
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Fluvoxamine Maleate (BP/USP)
    2022-06-08
    Application Number
    16174
    221MF10042
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-25
    Filing Details
    FLUVOXAMINE MALEATE USP
    FLUVOXAMINE MALEATE at SUN HOUSE, P...
    Fluvoxamine Maleate (BP/USP)
    Issue/Submission Date
    2002-09-24
    2009-02-23
    2022-06-08
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    Isotretinoin

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    USDMF

    Found USDMF

    32517
    Active
    ISOTRETINOIN USP
    2018-08-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-011 - Rev 06
    Valid
    Isotretinoin
    2023-05-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Isotretinoin (USP/EP/BP)
    2022-06-08
    Application Number
    32517
    R1-CEP 2002-011 - Rev 06
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-25
    Filing Details
    ISOTRETINOIN USP
    Isotretinoin
    Isotretinoin (USP/EP/BP)
    Issue/Submission Date
    2018-08-31
    2023-05-25
    2022-06-08
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    • FDA
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    Lansoprazole

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    USDMF

    Found USDMF

    22663
    Active
    LANSOPRAZOLE USP
    2009-04-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-219 - Rev 02
    Valid
    Lansoprazole
    2022-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Lansoprazole (USP/Ph.Eur.)
    2022-06-08
    Application Number
    22663
    R1-CEP 2008-219 - Rev 02
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-02
    Filing Details
    LANSOPRAZOLE USP
    Lansoprazole
    Lansoprazole (USP/Ph.Eur.)
    Issue/Submission Date
    2009-04-03
    2022-08-08
    2022-06-08
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    Letrozole

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    USDMF

    Found USDMF

    22632
    Active
    LETROZOLE USP
    2009-03-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-147 - Rev 01
    Valid
    Letrozole
    2022-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Letrozole (USP/EP/BP)
    2022-06-08
    Application Number
    22632
    R1-CEP 2009-147 - Rev 01
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-25
    Filing Details
    LETROZOLE USP
    Letrozole
    Letrozole (USP/EP/BP)
    Issue/Submission Date
    2009-03-25
    2022-03-08
    2022-06-08
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    Leuprolide Acetate

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    USDMF

    Found USDMF

    27832
    Active
    LEUPROLIDE ACETATE USP
    2014-01-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-278 - Rev 00
    Valid
    Leuprorelin
    2021-02-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Leuprolide Acetate (USP)
    2022-06-08
    Application Number
    27832
    R1-CEP 2014-278 - Rev 00
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-25
    Filing Details
    LEUPROLIDE ACETATE USP
    Leuprorelin
    Leuprolide Acetate (USP)
    Issue/Submission Date
    2014-01-24
    2021-02-26
    2022-06-08
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    • FDA
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    Metformin

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    USDMF

    Found USDMF

    15612
    Active
    METFORMIN HYDROCHLORIDE USP
    2001-08-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-122 - Rev 00
    Valid
    Metformin Hydrochloride, Xylene pro...
    2016-10-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Metformin Hydrochloride (USP/EP/BP)
    2022-06-08
    Application Number
    15612
    R1-CEP 2011-122 - Rev 00
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-25
    Filing Details
    METFORMIN HYDROCHLORIDE USP
    Metformin Hydrochloride, Xylene pro...
    Metformin Hydrochloride (USP/EP/BP)
    Issue/Submission Date
    2001-08-25
    2016-10-05
    2022-06-08
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    31453
    Active
    METOPROLOL SUCCINATE USP
    2017-03-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-197 - Rev 04
    Valid
    Metoprolol succinate
    2023-08-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Metoprolol Succinate Ph.Eur
    2022-06-08
    Application Number
    31453
    R1-CEP 2004-197 - Rev 04
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-02
    Filing Details
    METOPROLOL SUCCINATE USP
    Metoprolol succinate
    Metoprolol Succinate Ph.Eur
    Issue/Submission Date
    2017-03-01
    2023-08-22
    2022-06-08
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    Metoprolol Tartrate

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    USDMF

    Found USDMF

    15995
    Active
    METOPROLOL TARTRATE USP
    2002-05-18
    CEP/COS

    Found CEP/COS

    CEP 2018-086 - Rev 02
    Valid
    Metoprolol tartrate, Site II
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Metoprolol Tartrate (USP/EP/BP)
    2022-06-08
    Application Number
    15995
    CEP 2018-086 - Rev 02
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    METOPROLOL TARTRATE USP
    Metoprolol tartrate, Site II
    Metoprolol Tartrate (USP/EP/BP)
    Issue/Submission Date
    2002-05-18
    2024-03-25
    2022-06-08
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    Octreotide Acetate

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    USDMF

    Found USDMF

    17678
    Active
    OCTREOTIDE ACETATE USP (PROCESS I)
    2004-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10062
    Octreotide Acetate at SUN HOUSE, Pl...
    2014-03-06
    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Octreotide Acetate (IH)
    2022-06-08
    Application Number
    17678
    226MF10062
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    OCTREOTIDE ACETATE USP (PROCESS I)
    Octreotide Acetate at SUN HOUSE, Pl...
    Octreotide Acetate (IH)
    Issue/Submission Date
    2004-09-15
    2014-03-06
    2022-06-08
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    Olanzapine

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    USDMF

    Found USDMF

    21506
    Active
    OLANZAPINE USP
    2008-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-300 - Rev 01
    Valid
    Olanzapine
    2021-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Olanzepine (USP)
    2022-06-08
    Application Number
    21506
    R1-CEP 2012-300 - Rev 01
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    OLANZAPINE USP
    Olanzapine
    Olanzepine (USP)
    Issue/Submission Date
    2008-03-31
    2021-02-09
    2022-06-08
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    Oxaliplatin

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    USDMF

    Found USDMF

    19648
    Active
    OXALIPLATIN USP
    2006-08-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-044 - Rev 02
    Valid
    Oxaliplatin
    2019-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Oxaliplatin (USP/EP/BP)
    2022-06-08
    Application Number
    19648
    R1-CEP 2007-044 - Rev 02
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin
    Oxaliplatin (USP/EP/BP)
    Issue/Submission Date
    2006-08-04
    2019-11-08
    2022-06-08
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    Pantoprazole Sodium

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    USDMF

    Found USDMF

    17090
    Active
    PANTOPRAZOLE SODIUM USP
    2004-01-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-122 - Rev 02
    Valid
    Pantoprazole sodium sesquihydrate
    2020-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Pantoprazole Sodium Ph. Eur.
    2022-06-08
    Application Number
    17090
    R1-CEP 2009-122 - Rev 02
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-02
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium Ph. Eur.
    Issue/Submission Date
    2004-01-08
    2020-01-13
    2022-06-08
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    Pentoxifylline

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    USDMF

    Found USDMF

    14987
    Active
    PENTOXIFYLLINE USP
    2000-07-25
    CEP/COS

    Found CEP/COS

    CEP 1998-139 - Rev 06
    Valid
    Pentoxifylline
    2023-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Oxpentifylline/Pentoxifylline (USP/...
    2022-06-08
    Application Number
    14987
    CEP 1998-139 - Rev 06
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    PENTOXIFYLLINE USP
    Pentoxifylline
    Oxpentifylline/Pentoxifylline (USP/...
    Issue/Submission Date
    2000-07-25
    2023-10-02
    2022-06-08
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    Repaglinide

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    USDMF

    Found USDMF

    17825
    Active
    REPAGLINIDE USP
    2004-11-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-069 - Rev 02
    Valid
    Repaglinide
    2015-05-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Repaglinide (USP/Ph.Eur.)
    2022-06-08
    Application Number
    17825
    R1-CEP 2006-069 - Rev 02
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-02
    Filing Details
    REPAGLINIDE USP
    Repaglinide
    Repaglinide (USP/Ph.Eur.)
    Issue/Submission Date
    2004-11-10
    2015-05-26
    2022-06-08
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    31291
    Active
    ROSUVASTATIN CALCIUM USP
    2017-05-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-116 - Rev 03
    Valid
    Rosuvastatin calcium, Panoli site
    2022-11-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Rosuvastatin Calcium Ph. Eur.
    2022-06-08
    Application Number
    31291
    R0-CEP 2019-116 - Rev 03
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-02
    Filing Details
    ROSUVASTATIN CALCIUM USP
    Rosuvastatin calcium, Panoli site
    Rosuvastatin Calcium Ph. Eur.
    Issue/Submission Date
    2017-05-04
    2022-11-10
    2022-06-08
    ASK
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    Tamsulosin

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    USDMF

    Found USDMF

    21900
    Active
    TAMSULOSIN HYDROCHLORIDE USP
    2008-09-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-206 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2015-06-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Tamsulosin Hydrochloride (USP/Ph.Eu...
    2022-06-08
    Application Number
    21900
    R1-CEP 2008-206 - Rev 00
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-02
    Filing Details
    TAMSULOSIN HYDROCHLORIDE USP
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride (USP/Ph.Eu...
    Issue/Submission Date
    2008-09-27
    2015-06-10
    2022-06-08
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    34745
    Active
    Tramadol Hydrochloride USP (Process...
    2020-04-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-003 - Rev 00
    Valid
    Tramadol hydrochloride, Site-II
    2022-04-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Tramadol Hydrochloride (Ph.Eur.)
    2022-06-08
    Application Number
    34745
    R1-CEP 2016-003 - Rev 00
    Indian CDSCO WC-0011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-06-02
    Filing Details
    Tramadol Hydrochloride USP (Process...
    Tramadol hydrochloride, Site-II
    Tramadol Hydrochloride (Ph.Eur.)
    Issue/Submission Date
    2020-04-29
    2022-04-25
    2022-06-08
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    Venlafaxine Hydrochloride

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    USDMF

    Found USDMF

    19799
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2006-09-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-275 - Rev 01
    Valid
    Venlafaxine hydrochloride
    2015-05-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Venlafaxine Hydrochloride (USP/EP/B...
    2022-06-08
    Application Number
    19799
    R1-CEP 2006-275 - Rev 01
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride
    Venlafaxine Hydrochloride (USP/EP/B...
    Issue/Submission Date
    2006-09-22
    2015-05-22
    2022-06-08
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    Atorvastatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25657
    Inactive
    ATORVASTATIN CALCIUM (AMORPHOUS)
    2012-02-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-094 - Rev 03
    Valid
    Atorvastatin calcium, Process-IV
    2023-02-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Atorvastatin Calcium (USP)
    2022-06-08
    Application Number
    25657
    R1-CEP 2013-094 - Rev 03
    Indian CDSCO WC-0159
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    ATORVASTATIN CALCIUM (AMORPHOUS)
    Atorvastatin calcium, Process-IV
    Atorvastatin Calcium (USP)
    Issue/Submission Date
    2012-02-20
    2023-02-21
    2022-06-08
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    Budesonide

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    USDMF

    Found USDMF

    26445
    Active
    BUDESONIDE USP
    2013-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-064 - Rev 00
    Valid
    Budesonide
    2019-04-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Budesonide IP/USP/EP/BP
    2019-07-15
    Application Number
    26445
    R0-CEP 2018-064 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    BUDESONIDE USP
    Budesonide
    Budesonide IP/USP/EP/BP
    Issue/Submission Date
    2013-09-30
    2019-04-01
    2019-07-15
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    Buprenorphine Hydrochloride

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    USDMF

    Found USDMF

    22856
    Active
    BUPRENORPHINE HYDROCHLORIDE USP
    2009-08-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-312 - Rev 00
    Valid
    Buprenorphine hydrochloride
    2017-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Buprenorphine Hydrochloride EP/BP/U...
    2019-07-15
    Application Number
    22856
    R1-CEP 2009-312 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    BUPRENORPHINE HYDROCHLORIDE USP
    Buprenorphine hydrochloride
    Buprenorphine Hydrochloride EP/BP/U...
    Issue/Submission Date
    2009-08-27
    2017-11-08
    2019-07-15
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    Carvedilol

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    USDMF

    Found USDMF

    17590
    Active
    CARVEDILOL USP
    2004-08-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-230 - Rev 05
    Valid
    Carvedilol
    2015-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Carvedilol IP/USP/EP/BP
    2019-07-15
    Application Number
    17590
    R1-CEP 2004-230 - Rev 05
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    CARVEDILOL USP
    Carvedilol
    Carvedilol IP/USP/EP/BP
    Issue/Submission Date
    2004-08-10
    2015-07-28
    2019-07-15
    ASK
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    Clomipramine Hydrochloride

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    USDMF

    Found USDMF

    32996
    Active
    CLOMIPRAMINE HYDROCHLORIDE USP
    2018-12-27
    CEP/COS

    Found CEP/COS

    CEP 2001-163 - Rev 07
    Valid
    Clomipramine Hydrochloride
    2023-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Clomipramine HCl IP/USP/EP/BP
    2019-07-15
    Application Number
    32996
    CEP 2001-163 - Rev 07
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    CLOMIPRAMINE HYDROCHLORIDE USP
    Clomipramine Hydrochloride
    Clomipramine HCl IP/USP/EP/BP
    Issue/Submission Date
    2018-12-27
    2023-11-20
    2019-07-15
    ASK
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    Divalproex Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21410
    Active
    VALPROIC ACID USP
    2008-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-310 - Rev 04
    Valid
    Valproic acid
    2020-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-243
    Expired
    Divalproex Sodium (USP)/Valproic Ac...
    2019-09-11
    Application Number
    21410
    R1-CEP 2006-310 - Rev 04
    Indian CDSCO WC-243
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-09-10
    Filing Details
    VALPROIC ACID USP
    Valproic acid
    Divalproex Sodium (USP)/Valproic Ac...
    Issue/Submission Date
    2008-03-08
    2020-03-11
    2019-09-11
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    Esomeprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23199
    Active
    ESOMEPRAZOLE SODIUM
    2009-11-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-393 - Rev 00
    Valid
    Esomeprazole sodium
    2022-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Esomeprazole Sodium IH
    2019-07-15
    Application Number
    23199
    R0-CEP 2020-393 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ESOMEPRAZOLE SODIUM
    Esomeprazole sodium
    Esomeprazole Sodium IH
    Issue/Submission Date
    2009-11-16
    2022-11-24
    2019-07-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Levetiracetam

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    USDMF

    Found USDMF

    21414
    Active
    LEVETIRACETAM USP
    2008-03-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-034 - Rev 00
    Valid
    Levetiracetam
    2022-10-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Levetriacetam IP/USP/EP
    2019-07-15
    Application Number
    21414
    R0-CEP 2021-034 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam
    Levetriacetam IP/USP/EP
    Issue/Submission Date
    2008-03-05
    2022-10-12
    2019-07-15
    ASK
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    your Marketing & Sales content
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    Metoprolol Succinate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20646
    Inactive
    METOPROLOL SUCCINATE USP
    2007-06-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-139 - Rev 01
    Valid
    Metoprolol succinate, Site-II
    2020-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Metoprolol Succinate (USP/EP/BP)
    2022-06-08
    Application Number
    20646
    R0-CEP 2017-139 - Rev 01
    Indian CDSCO WC-0159
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    METOPROLOL SUCCINATE USP
    Metoprolol succinate, Site-II
    Metoprolol Succinate (USP/EP/BP)
    Issue/Submission Date
    2007-06-26
    2020-03-26
    2022-06-08
    ASK
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    Mirtazapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16113
    Active
    MIRTAZAPINE USP [HEMIHYDRATE]
    2002-08-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-293 - Rev 00
    Valid
    Mirtazapine
    2018-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Mirtazapine (EP/BP/USP)
    2019-07-15
    Application Number
    16113
    R1-CEP 2010-293 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    MIRTAZAPINE USP [HEMIHYDRATE]
    Mirtazapine
    Mirtazapine (EP/BP/USP)
    Issue/Submission Date
    2002-08-22
    2018-04-05
    2019-07-15
    ASK
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    Naloxone Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    23389
    Active
    NALOXONE HYDROCHLORIDE DIHYDRATE US...
    2010-02-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-135 - Rev 00
    Valid
    Naloxone hydrochloride dihydrate
    2019-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Naloxone Hydrochloride IP/USP, Nalo...
    2019-07-15
    Application Number
    23389
    R0-CEP 2017-135 - Rev 00
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    NALOXONE HYDROCHLORIDE DIHYDRATE US...
    Naloxone hydrochloride dihydrate
    Naloxone Hydrochloride IP/USP, Nalo...
    Issue/Submission Date
    2010-02-22
    2019-02-06
    2019-07-15
    ASK
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    • FDA
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    Ondansetron Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16562
    Active
    ONDANSETRON HYDROCHLORIDE USP
    2003-04-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-066 - Rev 04
    Valid
    Ondansetron hydrochloride dihydrate
    2022-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Ondansetron HCl (EP/BP/USP)
    2019-07-15
    Application Number
    16562
    R1-CEP 2004-066 - Rev 04
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ONDANSETRON HYDROCHLORIDE USP
    Ondansetron hydrochloride dihydrate
    Ondansetron HCl (EP/BP/USP)
    Issue/Submission Date
    2003-04-23
    2022-08-17
    2019-07-15
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    Sertraline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    19047
    Inactive
    SERTRALINE HYDROCHLORIDE
    2005-12-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-265 - Rev 01
    Valid
    Sertraline hydrochloride
    2020-05-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0011
    Valid
    Sertraline Hydrochloride Ph.Eur
    2022-06-08
    Application Number
    19047
    R1-CEP 2008-265 - Rev 01
    Indian CDSCO WC-0011
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-02
    Filing Details
    SERTRALINE HYDROCHLORIDE
    Sertraline hydrochloride
    Sertraline Hydrochloride Ph.Eur
    Issue/Submission Date
    2005-12-22
    2020-05-27
    2022-06-08
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    Sodium Valproate

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    USDMF

    Caution USDMF

    18016
    Inactive
    SODIUM VALPORATE EP
    2005-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-027 - Rev 04
    Valid
    Sodium valproate
    2020-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Sodium Valproate (EP/BP)
    2022-06-08
    Application Number
    18016
    R1-CEP 2004-027 - Rev 04
    Indian CDSCO WC-0159
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-25
    Filing Details
    SODIUM VALPORATE EP
    Sodium valproate
    Sodium Valproate (EP/BP)
    Issue/Submission Date
    2005-01-19
    2020-12-16
    2022-06-08
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    Sumatriptan

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    USDMF

    Found USDMF

    19372
    Active
    SUMATRIPTAN SUCCINATE USP
    2006-04-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-139 - Rev 01
    Valid
    Sumatriptan succinate
    2018-06-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Sumatriptan Succinate USP/EP/BP/IP
    2019-07-15
    Application Number
    19372
    R1-CEP 2009-139 - Rev 01
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    SUMATRIPTAN SUCCINATE USP
    Sumatriptan succinate
    Sumatriptan Succinate USP/EP/BP/IP
    Issue/Submission Date
    2006-04-19
    2018-06-18
    2019-07-15
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33770
    Active
    VALSARTAN USP
    2019-06-28
    CEP/COS

    Found CEP/COS

    CEP 2013-335 - Rev 06
    Valid
    Valsartan, Process 5
    2024-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0216
    Expired
    Valsartan (Ph. Eur)
    2019-07-05
    Application Number
    33770
    CEP 2013-335 - Rev 06
    Indian CDSCO WC-0216
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-04
    Filing Details
    VALSARTAN USP
    Valsartan, Process 5
    Valsartan (Ph. Eur)
    Issue/Submission Date
    2019-06-28
    2024-01-19
    2019-07-05
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    Zolpidem Tartrate

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    USDMF

    Found USDMF

    17712
    Active
    ZOLPIDEM TARTRATE USP
    2004-09-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-067 - Rev 02
    Valid
    Zolpidem tartrate
    2019-05-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0168
    Expired
    Zolpidem Tartrate IP/BP/EP/USP
    2019-07-15
    Application Number
    17712
    R1-CEP 2005-067 - Rev 02
    Indian CDSCO WC-0168
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ZOLPIDEM TARTRATE USP
    Zolpidem tartrate
    Zolpidem Tartrate IP/BP/EP/USP
    Issue/Submission Date
    2004-09-30
    2019-05-03
    2019-07-15
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    Amifostine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    17186
    Active
    AMIFOSTINE USP
    2004-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Amifostine (USP)
    2022-06-08
    Application Number
    17186
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    AMIFOSTINE USP
    Amifostine (USP)
    Issue/Submission Date
    2004-02-26
    2022-06-08
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    Betamethasone Dipropionate

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    See all info for this product

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    USDMF

    Found USDMF

    14651
    Active
    BETAMETHASONE DIPROPIONATE USP, MIC...
    1999-12-30
    CEP/COS

    Found CEP/COS

    CEP 2018-018 - Rev 02
    Valid
    Betamethasone dipropionate, Microni...
    2024-03-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14651
    CEP 2018-018 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BETAMETHASONE DIPROPIONATE USP, MIC...
    Betamethasone dipropionate, Microni...
    Issue/Submission Date
    1999-12-30
    2024-03-19
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    Clorazepate Dipotassium

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    See all info for this product

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    USDMF

    Found USDMF

    14169
    Active
    CLORAZEPATE DIPOTASSIUM USP
    1999-06-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-386 - Rev 01
    Valid
    Dipotassium clorazepate monohydrate
    2020-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14169
    R1-CEP 2009-386 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLORAZEPATE DIPOTASSIUM USP
    Dipotassium clorazepate monohydrate
    Issue/Submission Date
    1999-06-02
    2020-06-22
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    Etodolac

    PDF Supplier PDF
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    NA Not Available For Sales
    See all info for this product

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    USDMF

    Found USDMF

    15339
    Active
    ETODOLAC USP MICRONIZED
    2001-04-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-082 - Rev 06
    Valid
    Etodolac, Micronised
    2023-04-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15339
    R1-CEP 2004-082 - Rev 06
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ETODOLAC USP MICRONIZED
    Etodolac, Micronised
    Issue/Submission Date
    2001-04-13
    2023-04-03
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    Gabapentin

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    USDMF

    Found USDMF

    17240
    Active
    GABAPENTIN USP
    2004-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0159
    Valid
    Gabapentin (USP)
    2022-06-08
    Application Number
    17240
    Indian CDSCO WC-0159
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    GABAPENTIN USP
    Gabapentin (USP)
    Issue/Submission Date
    2004-03-18
    2022-06-08
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    Glycine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    1271
    Active
    AMINOACETIC ACID (GLYCINE)
    1968-12-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-213 - Rev 00
    Valid
    Glycine
    2021-09-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1271
    R0-CEP 2019-213 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMINOACETIC ACID (GLYCINE)
    Glycine
    Issue/Submission Date
    1968-12-13
    2021-09-03
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    Warfarin Sodium

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    USDMF

    Found USDMF

    12746
    Active
    WARFARIN SODIUM CLATHRATE USP
    1997-11-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-372 - Rev 04
    Valid
    Warfarin sodium clathrate
    2018-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12746
    R1-CEP 2001-372 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    WARFARIN SODIUM CLATHRATE USP
    Warfarin sodium clathrate
    Issue/Submission Date
    1997-11-18
    2018-11-16
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