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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Harman Finochem

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    Harman Finochem
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    Country
    Country
    India
    Address
    Address
    107-A,Vinay Bhavya Complex, 159-A, C.S.T. Road, Kalina, Santacruz (East), Mumbai - 400 098, Maharashtra
    Telephone
    Telephone
    +91 22 652 8080 / 67330100
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://harmanfinochem.com/
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    Twitter
    https://twitter.com/harmanfinochem?lang=en

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    • FDA
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    Allopurinol

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    USDMF

    Found USDMF

    17128
    Active
    ALLOPURINOL
    2004-01-28
    CEP/COS

    Found CEP/COS

    CEP 2001-433 - Rev 05
    Valid
    Allopurinol
    2024-03-11
    Japanese DMF

    Found JDMF

    231MF10078
    Allopurinol at 107-A, Vinay Bhavya ...
    2019-03-29
    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Allopurinol (BP/EP/USP)
    2022-06-06
    Application Number
    17128
    CEP 2001-433 - Rev 05
    231MF10078
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    ALLOPURINOL
    Allopurinol
    Allopurinol at 107-A, Vinay Bhavya ...
    Allopurinol (BP/EP/USP)
    Issue/Submission Date
    2004-01-28
    2024-03-11
    2019-03-29
    2022-06-06
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    • FDA
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    Metformin

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    USDMF

    Found USDMF

    15217
    Active
    METFORMIN HYDROCHLORIDE
    2001-01-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-059 - Rev 12
    Valid
    Metformin Hydrochloride
    2022-11-23
    Japanese DMF

    Found JDMF

    301MF10009
    Japanese Pharmacopoeia Metformin Hy...
    2019-05-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Metformin HCL (BP/EP/USP)
    2022-06-06
    Application Number
    15217
    R1-CEP 2000-059 - Rev 12
    301MF10009
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    METFORMIN HYDROCHLORIDE
    Metformin Hydrochloride
    Japanese Pharmacopoeia Metformin Hy...
    Metformin HCL (BP/EP/USP)
    Issue/Submission Date
    2001-01-02
    2022-11-23
    2019-05-28
    2022-06-06
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    • FDA
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    Divalproex Sodium

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    USDMF

    Found USDMF

    21532
    Active
    DIVALPROEX SODIUM USP
    2008-04-15
    CEP/COS

    Found CEP/COS

    CEP 2015-158 - Rev 01
    Valid
    Valproic acid
    2024-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Divalproex Sodium (USP) /Valproic ...
    2022-06-06
    Application Number
    21532
    CEP 2015-158 - Rev 01
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    DIVALPROEX SODIUM USP
    Valproic acid
    Divalproex Sodium (USP) /Valproic ...
    Issue/Submission Date
    2008-04-15
    2024-04-05
    2022-06-06
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    • FDA
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    Fenofibrate

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    USDMF

    Found USDMF

    23281
    Active
    FENOFIBRATE USP
    2009-11-19
    CEP/COS

    Found CEP/COS

    CEP 2008-023 - Rev 04
    Valid
    Fenofibrate, Non-micronised, micron...
    2024-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Finofibrate (BP/EP/USP)
    2022-06-06
    Application Number
    23281
    CEP 2008-023 - Rev 04
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    FENOFIBRATE USP
    Fenofibrate, Non-micronised, micron...
    Finofibrate (BP/EP/USP)
    Issue/Submission Date
    2009-11-19
    2024-02-09
    2022-06-06
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    • FDA
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    19710
    Active
    GLYCOPYRROLATE USP
    2006-08-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-017 - Rev 01
    Valid
    Glycopyrronium bromide
    2020-12-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Glycopyrrolate (USP)
    2022-06-08
    Application Number
    19710
    R1-CEP 2012-017 - Rev 01
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    GLYCOPYRROLATE USP
    Glycopyrronium bromide
    Glycopyrrolate (USP)
    Issue/Submission Date
    2006-08-28
    2020-12-01
    2022-06-08
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    Isoproterenol Hydrochloride

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    USDMF

    Found USDMF

    30707
    Active
    ISOPROTERENOL HYDROCHLORIDE USP
    2016-07-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-148 - Rev 00
    Valid
    Isoprenaline hydrochloride
    2021-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Isoprenaline Hydrochloride (BP/EP/...
    2022-06-06
    Application Number
    30707
    R0-CEP 2019-148 - Rev 00
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE USP
    Isoprenaline hydrochloride
    Isoprenaline Hydrochloride (BP/EP/...
    Issue/Submission Date
    2016-07-23
    2021-09-15
    2022-06-06
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    Lidocaine

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    USDMF

    Found USDMF

    27180
    Active
    LIDOCAINE USP
    2013-05-24
    CEP/COS

    Found CEP/COS

    CEP 2014-234 - Rev 01
    Valid
    Lidocaine
    2024-04-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Lidocaine (EP/USP)
    2022-06-08
    Application Number
    27180
    CEP 2014-234 - Rev 01
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    LIDOCAINE USP
    Lidocaine
    Lidocaine (EP/USP)
    Issue/Submission Date
    2013-05-24
    2024-04-03
    2022-06-08
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    Lidocaine Hydrochloride

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    USDMF

    Found USDMF

    28784
    Active
    LIDOCAINE HCL USP
    2014-10-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-044 - Rev 00
    Valid
    Lidocaine hydrochloride monohydrate
    2021-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Lidocaine Hydrochloride (EP/USP)
    2022-06-08
    Application Number
    28784
    R1-CEP 2015-044 - Rev 00
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    LIDOCAINE HCL USP
    Lidocaine hydrochloride monohydrate
    Lidocaine Hydrochloride (EP/USP)
    Issue/Submission Date
    2014-10-28
    2021-07-12
    2022-06-08
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    Metformin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-007 - Rev 01
    Valid
    Metformin Hydrochloride, (Process-I...
    2022-06-09
    Japanese DMF

    Found JDMF

    230MF10085
    Japanese Pharmacopoeia Metformin Hy...
    2018-07-13
    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Metformin HCL (EP/BP/USP)
    2022-06-08
    Application Number
    R0-CEP 2022-007 - Rev 01
    230MF10085
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Metformin Hydrochloride, (Process-I...
    Japanese Pharmacopoeia Metformin Hy...
    Metformin HCL (EP/BP/USP)
    Issue/Submission Date
    2022-06-09
    2018-07-13
    2022-06-08
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    • FDA
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    Neostigmine Methylsulfate

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    USDMF

    Found USDMF

    30136
    Active
    NEOSTIGMINE METHYLSULFATE USP
    2015-12-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-122 - Rev 01
    Valid
    Neostigmine metilsulfate
    2021-01-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Neostigmine Methylsulfate (EP)
    2022-06-08
    Application Number
    30136
    R0-CEP 2019-122 - Rev 01
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    NEOSTIGMINE METHYLSULFATE USP
    Neostigmine metilsulfate
    Neostigmine Methylsulfate (EP)
    Issue/Submission Date
    2015-12-31
    2021-01-08
    2022-06-08
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    Norepinephrine Bitartrate

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    USDMF

    Found USDMF

    33127
    Active
    NOREPINEPHRINE BITARTRATE USP
    2018-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-253 - Rev 00
    Valid
    Noradrenaline tartrate
    2023-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Norepinephrine Bitartrate USPI Nora...
    2022-06-06
    Application Number
    33127
    R0-CEP 2022-253 - Rev 00
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    NOREPINEPHRINE BITARTRATE USP
    Noradrenaline tartrate
    Norepinephrine Bitartrate USPI Nora...
    Issue/Submission Date
    2018-09-30
    2023-08-08
    2022-06-06
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    • FDA
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    Oxybutynin Hydrochloride

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    USDMF

    Found USDMF

    22852
    Active
    OXYBUTYNIN CHLORIDE
    2009-06-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-348 - Rev 00
    Valid
    Oxybutynin hydrochloride, Process I...
    2022-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Oxybutynine Hydrochloride (BP/EP)
    2022-06-08
    Application Number
    22852
    R0-CEP 2022-348 - Rev 00
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    OXYBUTYNIN CHLORIDE
    Oxybutynin hydrochloride, Process I...
    Oxybutynine Hydrochloride (BP/EP)
    Issue/Submission Date
    2009-06-12
    2022-11-03
    2022-06-08
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    • FDA
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    Phenobarbital

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17823
    Active
    PHENOBARBITAL USP
    2004-11-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-017 - Rev 03
    Valid
    Phenobarbital
    2015-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Phenobarbital (BP/EP/USP)
    2022-06-06
    Application Number
    17823
    R1-CEP 2003-017 - Rev 03
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    PHENOBARBITAL USP
    Phenobarbital
    Phenobarbital (BP/EP/USP)
    Issue/Submission Date
    2004-11-10
    2015-07-21
    2022-06-06
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    Phenytoin Sodium

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    USDMF

    Found USDMF

    17862
    Active
    PHENYTOIN SODIUM USP
    2004-12-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-038 - Rev 00
    Valid
    Phenytoin sodium
    2023-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Phenytoin Sodium (BP/EP/USP)
    2022-06-06
    Application Number
    17862
    R1-CEP 2016-038 - Rev 00
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    PHENYTOIN SODIUM USP
    Phenytoin sodium
    Phenytoin Sodium (BP/EP/USP)
    Issue/Submission Date
    2004-12-02
    2023-01-11
    2022-06-06
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    • FDA
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34287
    Active
    VALSARTAN USP
    2019-11-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-026 - Rev 00
    Valid
    Valsartan
    2023-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Valsartan EP
    2022-06-06
    Application Number
    34287
    R1-CEP 2016-026 - Rev 00
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    VALSARTAN USP
    Valsartan
    Valsartan EP
    Issue/Submission Date
    2019-11-19
    2023-01-26
    2022-06-06
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    • FDA
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    Meprobamate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20674
    Active
    MEPROBAMATE USP
    2007-07-13
    CEP/COS

    Caution CEP/COS

    R1-CEP 2009-322 - Rev 00
    Withdrawn by EDQM Failure to CEP procedure
    Meprobamate - Text Deleted 1/01/202...
    2016-05-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Meprobamate (BP/EP/USP)
    2022-06-06
    Application Number
    20674
    R1-CEP 2009-322 - Rev 00
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Valid
    2025-07-21
    Filing Details
    MEPROBAMATE USP
    Meprobamate - Text Deleted 1/01/202...
    Meprobamate (BP/EP/USP)
    Issue/Submission Date
    2007-07-13
    2016-05-11
    2022-06-06
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    Bisoprolol Fumarate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-264 - Rev 01
    Valid
    Bisoprolol fumarate
    2022-10-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Bisoprolol Fumarate (EP/USP)
    2022-06-08
    Application Number
    R1-CEP 2014-264 - Rev 01
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Bisoprolol fumarate
    Bisoprolol Fumarate (EP/USP)
    Issue/Submission Date
    2022-10-12
    2022-06-08
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    Carisoprodol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21064
    Active
    CARISOPRODOL USP
    2007-11-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Carisoprodol (BP/EP/USP)
    2022-06-06
    Application Number
    21064
    Indian CDSCO WC-0044
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    CARISOPRODOL USP
    Carisoprodol (BP/EP/USP)
    Issue/Submission Date
    2007-11-27
    2022-06-06
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    Choline Fenofibrate

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    USDMF

    Found USDMF

    28282
    Active
    CHOLINE FENOFIBRATE
    2014-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Choline Fenofibrate
    2022-06-08
    Application Number
    28282
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    CHOLINE FENOFIBRATE
    Choline Fenofibrate
    Issue/Submission Date
    2014-05-28
    2022-06-08
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    Levomethadone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-380 - Rev 00
    Valid
    Levomethadone hydrochloride
    2022-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Levomethadone Hydrochloride (EP)
    2022-06-08
    Application Number
    R1-CEP 2015-380 - Rev 00
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Levomethadone hydrochloride
    Levomethadone Hydrochloride (EP)
    Issue/Submission Date
    2022-02-11
    2022-06-08
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    Linagliptin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38819
    Active
    LINAGLIPTIN
    2023-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Linagliptin
    2022-06-08
    Application Number
    38819
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    LINAGLIPTIN
    Linagliptin
    Issue/Submission Date
    2023-09-27
    2022-06-08
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    Methadone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-086 - Rev 00
    Valid
    Methadone hydrochloride
    2018-10-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Methadone Hydrochloride (BP/EP/USP)
    2022-06-08
    Application Number
    R1-CEP 2011-086 - Rev 00
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Methadone hydrochloride
    Methadone Hydrochloride (BP/EP/USP)
    Issue/Submission Date
    2018-10-17
    2022-06-08
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    Methylphenidate Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-031 - Rev 02
    Valid
    Methylphenidate hydrochloride
    2022-04-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Methyl Phenidate Hydrochloride (EP/...
    2022-06-08
    Application Number
    R1-CEP 2010-031 - Rev 02
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Methylphenidate hydrochloride
    Methyl Phenidate Hydrochloride (EP/...
    Issue/Submission Date
    2022-04-08
    2022-06-08
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    Methylphenobarbital

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-202 - Rev 03
    Valid
    Methylphenobarbital
    2023-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Methylphenobarbital (BP/EP)
    2022-06-08
    Application Number
    R1-CEP 2005-202 - Rev 03
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Methylphenobarbital
    Methylphenobarbital (BP/EP)
    Issue/Submission Date
    2023-03-09
    2022-06-08
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    Oxiconazole Nitrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23625
    Active
    OXICONAZOLE NITRATE
    2010-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Oxyconazole Nitrate
    2022-06-08
    Application Number
    23625
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    OXICONAZOLE NITRATE
    Oxyconazole Nitrate
    Issue/Submission Date
    2010-03-16
    2022-06-08
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    Oxybutynin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37351
    Active
    R-OXYBUTYNIN HYDROCHLORIDE
    2022-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-101 - Rev 02
    Valid
    Oxybutynin hydrochloride
    2022-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37351
    R1-CEP 2008-101 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    R-OXYBUTYNIN HYDROCHLORIDE
    Oxybutynin hydrochloride
    Issue/Submission Date
    2022-09-26
    2022-03-29
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    Phenobarbital Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31499
    Active
    PHENOBARBITAL SODIUM USP
    2017-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Phenobarbital Sodium (BP/EP/USP)
    2022-06-08
    Application Number
    31499
    Indian CDSCO WC-0045
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    PHENOBARBITAL SODIUM USP
    Phenobarbital Sodium (BP/EP/USP)
    Issue/Submission Date
    2017-03-16
    2022-06-08
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    Propofol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    29006
    Inactive
    PROPOFOL USP
    2015-02-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-347 - Rev 00
    Valid
    Propofol
    2022-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0045A3
    Expired
    Propofol EP/USP
    2020-11-05
    Application Number
    29006
    R1-CEP 2015-347 - Rev 00
    Indian CDSCO WC-0045A3
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    PROPOFOL USP
    Propofol
    Propofol EP/USP
    Issue/Submission Date
    2015-02-17
    2022-07-28
    2020-11-05
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    Riboflavin 5 Phosphate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-254 - Rev 01
    Valid
    Riboflavin sodium phosphate hydrate
    2020-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Riboflavin Phosphate Sodium (IP/BP/...
    2022-06-08
    Application Number
    R1-CEP 2010-254 - Rev 01
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Riboflavin sodium phosphate hydrate
    Riboflavin Phosphate Sodium (IP/BP/...
    Issue/Submission Date
    2020-09-04
    2022-06-08
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    Sodium Valproate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-281 - Rev 00
    Valid
    Sodium valproate
    2022-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Sodium Valproate EP
    2022-06-06
    Application Number
    R1-CEP 2015-281 - Rev 00
    Indian CDSCO WC-0044
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Sodium valproate
    Sodium Valproate EP
    Issue/Submission Date
    2022-10-11
    2022-06-06
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    Succinylcholine Chloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31986
    Active
    SUCCINYLCHOLINE CHLORIDE USP
    2017-10-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10080
    Succinylcholine Chloride at 107-A, ...
    2022-05-25
    Written Confirmation

    Close WC

    Application Number
    31986
    304MF10080
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUCCINYLCHOLINE CHLORIDE USP
    Succinylcholine Chloride at 107-A, ...
    Issue/Submission Date
    2017-10-11
    2022-05-25
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    Torsemide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-304 - Rev 00
    Valid
    Torasemide
    2021-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Torasemide (EP)/USP
    2022-06-08
    Application Number
    R1-CEP 2014-304 - Rev 00
    Indian CDSCO WC-0045
    Status
    Valid
     
    Valid
    2025-07-21
    Filing Details
    Torasemide
    Torasemide (EP)/USP
    Issue/Submission Date
    2021-11-17
    2022-06-08
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    Vildagliptin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10127
    Vildagliptin at 107-A, Vinay Bhavya...
    2023-12-06
    Written Confirmation

    Found WC

    Indian CDSCO WC-0044
    Valid
    Vildagliptin IH
    2022-06-06
    Application Number
    305MF10127
    Indian CDSCO WC-0044
    Status
     
    Valid
    2025-07-21
    Filing Details
    Vildagliptin at 107-A, Vinay Bhavya...
    Vildagliptin IH
    Issue/Submission Date
    2023-12-06
    2022-06-06
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    • FDA
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    Glycopyrronium Tosylate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    34111
    Active
    GLYCOPYRROLATE TOSYLATE
    2019-09-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0045A4
    Expired
    Glycopyrrolate Tosylate IH
    2022-06-07
    Application Number
    34111
    Indian CDSCO WC-0045A4
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-21
    Filing Details
    GLYCOPYRROLATE TOSYLATE
    Glycopyrrolate Tosylate IH
    Issue/Submission Date
    2019-09-24
    2022-06-07
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    Allopurinol

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Allopurinol (IP/EP/BP/USP/JP)
    2022-06-08
    Application Number
    Indian CDSCO WC-0045
    Status
     
    Valid
    2025-07-21
    Filing Details
    Allopurinol (IP/EP/BP/USP/JP)
    Issue/Submission Date
    2022-06-08
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    • FDA
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    Benztropine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33126
    Active
    BENZTROPINE MESYLATE USP
    2018-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33126
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BENZTROPINE MESYLATE USP
    Issue/Submission Date
    2018-09-30
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    Copper Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37484
    Active
    CUPRIC SULFATE USP
    2022-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37484
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CUPRIC SULFATE USP
    Issue/Submission Date
    2022-09-30
    ASK
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    Dapagliflozin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32170
    Active
    DAPAGLIFLOZIN
    2017-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32170
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN
    Issue/Submission Date
    2017-11-09
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    Efinaconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32033
    Active
    EFINACONAZOLE
    2017-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32033
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EFINACONAZOLE
    Issue/Submission Date
    2017-12-06
    ASK
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    Fospropofol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    35337
    Active
    FOSPROPOFOL DISODIUM
    2020-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35337
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSPROPOFOL DISODIUM
    Issue/Submission Date
    2020-11-28
    ASK
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    Ketamine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-362 - Rev 01
    Valid
    Ketamine hydrochloride
    2014-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-362 - Rev 01
    Status
    Valid
     
    Filing Details
    Ketamine hydrochloride
    Issue/Submission Date
    2014-11-27
    ASK
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    • FDA
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    Manganese Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37485
    Active
    MANGANESE SULFATE USP
    2022-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37485
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MANGANESE SULFATE USP
    Issue/Submission Date
    2022-09-30
    ASK
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    • FDA
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    Methylphenidate Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-474 - Rev 00
    Valid
    Methylphenidate hydrochloride, Proc...
    2022-05-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-474 - Rev 00
    Status
    Valid
     
    Filing Details
    Methylphenidate hydrochloride, Proc...
    Issue/Submission Date
    2022-05-25
    ASK
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    • FDA
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    N-Desethyloxybutynin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35084
    Active
    DESETHYLOXYBUTYNIN HYDROCHLORIDE
    2020-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35084
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DESETHYLOXYBUTYNIN HYDROCHLORIDE
    Issue/Submission Date
    2020-09-10
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    • FDA
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    Oxiconazole Nitrate

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

    See Less

    USDMF

    Found USDMF

    23855
    Active
    FENOFIBRIC ACID
    2010-06-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23855
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FENOFIBRIC ACID
    Issue/Submission Date
    2010-06-03
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    Phenobarbital

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0045
    Valid
    Phenobarbital (BP/EP/USP)
    2022-06-08
    Application Number
    Indian CDSCO WC-0045
    Status
     
    Valid
    2025-07-21
    Filing Details
    Phenobarbital (BP/EP/USP)
    Issue/Submission Date
    2022-06-08
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    Potassium Acetate

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    USDMF

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    37019
    Active
    POTASSIUM ACETATE USP
    2022-05-06
    CEP/COS

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    Japanese DMF

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    Application Number
    37019
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POTASSIUM ACETATE USP
    Issue/Submission Date
    2022-05-06
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    Sacubitril-Valsartan

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    USDMF

    Found USDMF

    33452
    Active
    SACUBITRIL/VALSARTAN
    2019-02-01
    CEP/COS

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    Application Number
    33452
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SACUBITRIL/VALSARTAN
    Issue/Submission Date
    2019-02-01
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    Selenious Acid

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    USDMF

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    37486
    Active
    SELENIOUS ACID
    2022-10-01
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    Application Number
    37486
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SELENIOUS ACID
    Issue/Submission Date
    2022-10-01
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    Sitagliptin Phosphate

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    USDMF

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    CEP/COS

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    R0-CEP 2021-117 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2023-06-22
    Japanese DMF

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    Application Number
    R0-CEP 2021-117 - Rev 00
    Status
    Valid
     
    Filing Details
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2023-06-22
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