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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ami Lifesciences Private Limited

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    AMI Lifesciences
    Ami Lifesciences Private Limited
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    India
    Address
    Address
    701 to 710, 7th Floor, 1038 Lilleria, Gotri-Sevasi Road, New Alkapuri, Vadodara, Vadodara, Gujarat - 390021
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    +91 2652323046
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    info@amilifesciences.com
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    http://amilifesciences.com/
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2023-168 - Rev 00
    Valid
    Ambroxol hydrochloride, Process II
    2023-08-23
    Japanese DMF

    Found JDMF

    305MF10118
    Ambroxol Hydrochloride at 2nd Floor...
    2023-11-01
    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Ambroxol Hydrochloride EP
    2022-08-11
    Application Number
    R0-CEP 2023-168 - Rev 00
    305MF10118
    Indian CDSCO WC-0054
    Status
    Valid
     
    Valid
    2025-06-26
    Filing Details
    Ambroxol hydrochloride, Process II
    Ambroxol Hydrochloride at 2nd Floor...
    Ambroxol Hydrochloride EP
    Issue/Submission Date
    2023-08-23
    2023-11-01
    2022-08-11
    AMI Lifesciences

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    Diacerein

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    USDMF

    Found USDMF

    38766
    Active
    DIACEREIN
    2023-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-173 - Rev 02
    Valid
    Diacerein
    2022-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Diacerein IH/BP/EP
    2022-08-11
    Application Number
    38766
    R1-CEP 2015-173 - Rev 02
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-06-26
    Filing Details
    DIACEREIN
    Diacerein
    Diacerein IH/BP/EP
    Issue/Submission Date
    2023-09-15
    2022-04-04
    2022-08-11
    AMI Lifesciences

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    Tadalafil

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    USDMF

    Found USDMF

    37995
    Active
    TADALAFIL
    2023-02-10
    CEP/COS

    Found CEP/COS

    CEP 2014-339 - Rev 03
    Valid
    Tadalafil
    2024-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Tadalafil Ph.Eur.lBP/USP
    2022-08-11
    Application Number
    37995
    CEP 2014-339 - Rev 03
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-06-26
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil Ph.Eur.lBP/USP
    Issue/Submission Date
    2023-02-10
    2024-02-14
    2022-08-11
    AMI Lifesciences

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    Tranexamic Acid

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    USDMF

    Found USDMF

    36336
    Active
    TRANEXAMIC ACID USP
    2021-10-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-250 - Rev 02
    Valid
    Tranexamic acid
    2022-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Tranexamic Acid BP/USP/EP/JP
    2022-08-11
    Application Number
    36336
    R0-CEP 2019-250 - Rev 02
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Valid
    2025-06-26
    Filing Details
    TRANEXAMIC ACID USP
    Tranexamic acid
    Tranexamic Acid BP/USP/EP/JP
    Issue/Submission Date
    2021-10-07
    2022-04-04
    2022-08-11
    AMI Lifesciences

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    Benzonatate

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    USDMF

    Found USDMF

    39002
    Active
    BENZONATATE
    2023-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Benzonatate IH
    2022-08-11
    Application Number
    39002
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    BENZONATATE
    Benzonatate IH
    Issue/Submission Date
    2023-12-04
    2022-08-11
    AMI Lifesciences

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    Betahistine Dihydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-101 - Rev 03
    Valid
    Betahistine dihydrochloride
    2023-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Betahistine Dihydrochloride EP
    2022-08-11
    Application Number
    R1-CEP 2011-101 - Rev 03
    Indian CDSCO WC-0054
    Status
    Valid
     
    Valid
    2025-06-26
    Filing Details
    Betahistine dihydrochloride
    Betahistine Dihydrochloride EP
    Issue/Submission Date
    2023-02-10
    2022-08-11
    AMI Lifesciences

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    Brivaracetam

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    USDMF

    Found USDMF

    36655
    Active
    BRIVARACETAM
    2022-01-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Brivaracetam IH
    2022-08-11
    Application Number
    36655
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    BRIVARACETAM
    Brivaracetam IH
    Issue/Submission Date
    2022-01-08
    2022-08-11
    AMI Lifesciences

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    Desvenlafaxine Succinate

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    USDMF

    Found USDMF

    38066
    Active
    DESVENLAFAXINE SUCCINATE
    2023-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Desvenlafaxine Succinate IH/USP
    2022-08-11
    Application Number
    38066
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    DESVENLAFAXINE SUCCINATE
    Desvenlafaxine Succinate IH/USP
    Issue/Submission Date
    2023-03-03
    2022-08-11
    AMI Lifesciences

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    Eslicarbazepine Acetate

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    USDMF

    Found USDMF

    38309
    Active
    ESLICARBAZEPINE ACETATE
    2023-04-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Eslicarbazepine Acetate IH
    2022-08-11
    Application Number
    38309
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    ESLICARBAZEPINE ACETATE
    Eslicarbazepine Acetate IH
    Issue/Submission Date
    2023-04-25
    2022-08-11
    AMI Lifesciences

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    Febuxostat

    PDF Supplier PDF
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    Other DMF MX
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    See Less

    USDMF

    Found USDMF

    37996
    Active
    FEBUXOSTAT
    2023-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Febuxostat IH
    2022-08-11
    Application Number
    37996
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    FEBUXOSTAT
    Febuxostat IH
    Issue/Submission Date
    2023-02-03
    2022-08-11
    AMI Lifesciences

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    Rivaroxaban

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    USDMF

    Found USDMF

    37173
    Active
    RIVAROXABAN
    2022-06-06
    CEP/COS

    Found CEP/COS

    CEP 2022-215 - Rev 00
    Valid
    Rivaroxaban
    2024-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37173
    CEP 2022-215 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Issue/Submission Date
    2022-06-06
    2024-03-28
    AMI Lifesciences

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    Sacubitril-Valsartan

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    USDMF

    Found USDMF

    37994
    Active
    SACUBITRIL VALSARTAN TRISODIUM SALT...
    2023-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Sacubitril Valsartan Trisodium salt...
    2022-08-11
    Application Number
    37994
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    SACUBITRIL VALSARTAN TRISODIUM SALT...
    Sacubitril Valsartan Trisodium salt...
    Issue/Submission Date
    2023-03-09
    2022-08-11
    AMI Lifesciences

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    Sevelamer Carbonate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37981
    Active
    SEVELAMER CARBONATE
    2023-01-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Sevelamer Carbonate IH
    2022-08-11
    Application Number
    37981
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    SEVELAMER CARBONATE
    Sevelamer Carbonate IH
    Issue/Submission Date
    2023-01-25
    2022-08-11
    AMI Lifesciences

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    Sevelamer Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38016
    Active
    SEVELAMER HYDROCHLORIDE
    2023-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Sevelamer Hydrochloride IH
    2022-08-11
    Application Number
    38016
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    SEVELAMER HYDROCHLORIDE
    Sevelamer Hydrochloride IH
    Issue/Submission Date
    2023-03-01
    2022-08-11
    AMI Lifesciences

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    Tapentadol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-290 - Rev 00
    Valid
    Tapentadol hydrochloride
    2022-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Tapentadol Hydrochloride IH
    2022-08-11
    Application Number
    R0-CEP 2021-290 - Rev 00
    Indian CDSCO WC-0054
    Status
    Valid
     
    Valid
    2025-06-26
    Filing Details
    Tapentadol hydrochloride
    Tapentadol Hydrochloride IH
    Issue/Submission Date
    2022-11-24
    2022-08-11
    AMI Lifesciences

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    Vildagliptin

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF BR
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10086
    Vildagliptin at 2nd Floor, Prestige...
    2023-07-19
    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Vildagliptin IH
    2022-08-11
    Application Number
    305MF10086
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Vildagliptin at 2nd Floor, Prestige...
    Vildagliptin IH
    Issue/Submission Date
    2023-07-19
    2022-08-11
    AMI Lifesciences

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    Vonoprazan Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF BR
    See all info for this product

    See Less

    USDMF

    Found USDMF

    36262
    Active
    VONOPRAZAN FUMARATE
    2021-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Vonoprazan Fumarate IH
    2022-08-11
    Application Number
    36262
    Indian CDSCO WC-0054
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2025-06-26
    Filing Details
    VONOPRAZAN FUMARATE
    Vonoprazan Fumarate IH
    Issue/Submission Date
    2021-09-06
    2022-08-11
    AMI Lifesciences

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    Acebrophylline

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF BR, MX
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Acebrophyllin IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Acebrophyllin IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Alpha Lipoic Acid

    PDF Supplier PDF
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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-0054
    Valid
    Alpha Lipoic Acid USP
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Alpha Lipoic Acid USP
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Ambroxol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF MX
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-135 - Rev 03
    Valid
    Ambroxol hydrochloride
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2014-135 - Rev 03
    Status
    Valid
     
    Filing Details
    Ambroxol hydrochloride
    Issue/Submission Date
    2024-03-25
    AMI Lifesciences

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    Azilsartan

    PDF Supplier PDF
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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-0054
    Valid
    Azilsartan Medoxomil Potassium salt...
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Azilsartan Medoxomil Potassium salt...
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Bempedoic Acid

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    USDMF

    Found USDMF

    37511
    Active
    BEMPEDOIC ACID
    2022-10-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37511
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BEMPEDOIC ACID
    Issue/Submission Date
    2022-10-03
    AMI Lifesciences

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    Benfotiamine

    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-0054
    Valid
    Benfotiamina IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Benfotiamina IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Choline Fenofibrate

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    Other DMF MX
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Choline Fenofibrate IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Choline Fenofibrate IH
    Issue/Submission Date
    2022-08-11
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    Dapagliflozin

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    USDMF

    Found USDMF

    38009
    Active
    DAPAGLIFLOZIN AMORPHOUS
    2023-02-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38009
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DAPAGLIFLOZIN AMORPHOUS
    Issue/Submission Date
    2023-02-23
    AMI Lifesciences

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    Dapagliflozin Propanediol Monohydrate

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    USDMF

    Found USDMF

    38010
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2023-02-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38010
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Issue/Submission Date
    2023-02-23
    AMI Lifesciences

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    Dapoxetine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Dapoxetine Hydrochloride IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Dapoxetine Hydrochloride IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Daprodustat

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    USDMF

    Found USDMF

    38516
    Active
    DAPRODUSTAT
    2023-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38516
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DAPRODUSTAT
    Issue/Submission Date
    2023-06-30
    AMI Lifesciences

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    Doxofylline

    PDF Supplier PDF
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    Other DMF EU, MX
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Doxofylline IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Doxofylline IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Edoxaban Tosylate

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    USDMF

    Found USDMF

    38201
    Active
    EDOXABAN TOSYLATE MONOHYDRATE
    2023-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38201
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    EDOXABAN TOSYLATE MONOHYDRATE
    Issue/Submission Date
    2023-03-24
    AMI Lifesciences

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    Empagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38200
    Active
    EMPAGLIFLOZIN
    2023-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38200
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2023-03-29
    AMI Lifesciences

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    Fimasartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Fimasartan Potassium Ttihydrate IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Fimasartan Potassium Ttihydrate IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Finerenone

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    USDMF

    Found USDMF

    38889
    Active
    FINERENONE
    2023-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38889
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    FINERENONE
    Issue/Submission Date
    2023-09-28
    AMI Lifesciences

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    Flavoxate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF MX
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Flavoxate Hydrochloride BP/USP
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Flavoxate Hydrochloride BP/USP
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Gliclazide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-465 - Rev 00
    Valid
    Gliclazide
    2024-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-465 - Rev 00
    Status
    Valid
     
    Filing Details
    Gliclazide
    Issue/Submission Date
    2024-02-15
    AMI Lifesciences

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    Itopride Hydrochloride

    PDF Supplier PDF
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    Other DMF EU, MX
    See all info for this product

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Itopride Hydrochloride IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Itopride Hydrochloride IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Levocloperastine Fendizoate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Levocloperastine Fendizoate IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Levocloperastine Fendizoate IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Mirogabalin Besylate

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    USDMF

    Found USDMF

    39342
    Active
    MIROGABALIN BESYLATE
    2023-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39342
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MIROGABALIN BESYLATE
    Issue/Submission Date
    2023-12-29
    AMI Lifesciences

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    Obeticholic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Obeticholic Acid IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Obeticholic Acid IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Oxcarbazepine

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    USDMF

    Found USDMF

    38017
    Active
    OXCARBAZEPINE
    2023-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38017
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    OXCARBAZEPINE
    Issue/Submission Date
    2023-03-15
    AMI Lifesciences

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    Pamabrom

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Pamabrom USP
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Pamabrom USP
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Rutin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Rutoside Trihydrate Ph.Eur
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Rutoside Trihydrate Ph.Eur
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Sacubitril Sodium

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    USDMF

    Found USDMF

    38140
    Active
    SACUBITRIL SODIUM
    2023-03-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38140
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SACUBITRIL SODIUM
    Issue/Submission Date
    2023-03-17
    AMI Lifesciences

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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    37030
    Active
    SITAGLIPTIN PHOSPHATE USP
    2022-05-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37030
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SITAGLIPTIN PHOSPHATE USP
    Issue/Submission Date
    2022-05-02
    AMI Lifesciences

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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    39354
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    2024-01-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39354
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    Issue/Submission Date
    2024-01-20
    AMI Lifesciences

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    Teneligliptin Hydrobromide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0054
    Valid
    Teneligliptin Hydrobromide IH
    2022-08-11
    Application Number
    Indian CDSCO WC-0054
    Status
     
    Valid
    2025-06-26
    Filing Details
    Teneligliptin Hydrobromide IH
    Issue/Submission Date
    2022-08-11
    AMI Lifesciences

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    Venlafaxine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-353 - Rev 00
    Valid
    Venlafaxine hydrochloride
    2023-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-353 - Rev 00
    Status
    Valid
     
    Filing Details
    Venlafaxine hydrochloride
    Issue/Submission Date
    2023-03-28
    AMI Lifesciences

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    Vibegron

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    USDMF

    Found USDMF

    39538
    Active
    VIBEGRON
    2024-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39538
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    VIBEGRON
    Issue/Submission Date
    2024-03-21
    AMI Lifesciences

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    Deucravacitinib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    AMI Lifesciences

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    Resmetirom

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    AMI Lifesciences

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