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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Aurore Life Sciences

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    • FDA
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    Aciclovir

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    USDMF

    Found USDMF

    34516
    Active
    ACYCLOVIR USP
    2020-01-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-013 - Rev 01
    Valid
    Aciclovir
    2022-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Acyclovir
    2022-09-19
    Application Number
    34516
    R0-CEP 2020-013 - Rev 01
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ACYCLOVIR USP
    Aciclovir
    Acyclovir
    Issue/Submission Date
    2020-01-28
    2022-10-25
    2022-09-19
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    34318
    Active
    AMLODIPINE BESYLATE USP
    2019-11-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-310 - Rev 00
    Valid
    Amlodipine besilate
    2021-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Amlodipine Besylate
    2022-09-19
    Application Number
    34318
    R0-CEP 2019-310 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    AMLODIPINE BESYLATE USP
    Amlodipine besilate
    Amlodipine Besylate
    Issue/Submission Date
    2019-11-22
    2021-08-16
    2022-09-19
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    • FDA
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    Celecoxib

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    USDMF

    Found USDMF

    34070
    Active
    CELECOXIB USP
    2019-08-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-112 - Rev 00
    Valid
    Celecoxib
    2021-04-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Celecoxib (Ph. Eur.)
    2022-09-19
    Application Number
    34070
    R0-CEP 2019-112 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib (Ph. Eur.)
    Issue/Submission Date
    2019-08-08
    2021-04-09
    2022-09-19
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    • FDA
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    Clozapine

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    USDMF

    Found USDMF

    36645
    Active
    CLOZAPINE USP
    2021-12-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-110 - Rev 00
    Valid
    Clozapine
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Clozapine Ph.Eur
    2022-09-19
    Application Number
    36645
    R0-CEP 2021-110 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CLOZAPINE USP
    Clozapine
    Clozapine Ph.Eur
    Issue/Submission Date
    2021-12-23
    2022-07-08
    2022-09-19
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    Dronedarone Hydrochloride

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    USDMF

    Found USDMF

    35913
    Active
    DRONEDARONE HYDROCHLORIDE USP
    2021-05-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-266 - Rev 01
    Valid
    Dronedarone hydrochloride
    2023-04-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Dronedarone Hydrochloride Ph.Eur I...
    2022-09-19
    Application Number
    35913
    R0-CEP 2020-266 - Rev 01
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DRONEDARONE HYDROCHLORIDE USP
    Dronedarone hydrochloride
    Dronedarone Hydrochloride Ph.Eur I...
    Issue/Submission Date
    2021-05-31
    2023-04-27
    2022-09-19
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    • FDA
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    Levetiracetam

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    USDMF

    Found USDMF

    34097
    Active
    LEVETIRACETAM USP
    2019-08-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-157 - Rev 00
    Valid
    Levetiracetam
    2021-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Levetiracetam USP/Ph.Eur/BP
    2022-09-19
    Application Number
    34097
    R0-CEP 2019-157 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam
    Levetiracetam USP/Ph.Eur/BP
    Issue/Submission Date
    2019-08-26
    2021-02-25
    2022-09-19
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    Levothyroxine Sodium

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    USDMF

    Found USDMF

    34044
    Active
    LEVOTHYROXINE SODIUM USP
    2019-08-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-190 - Rev 01
    Valid
    Levothyroxine sodium
    2023-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Levothyroxine sodium
    2022-09-19
    Application Number
    34044
    R0-CEP 2019-190 - Rev 01
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LEVOTHYROXINE SODIUM USP
    Levothyroxine sodium
    Levothyroxine sodium
    Issue/Submission Date
    2019-08-05
    2023-05-31
    2022-09-19
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    • FDA
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    Losartan Potassium

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    USDMF

    Found USDMF

    35076
    Active
    LOSARTAN POTASSIUM USP
    2020-09-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-087 - Rev 00
    Valid
    Losartan potassium
    2022-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Losartan Potassium USP
    2022-09-19
    Application Number
    35076
    R0-CEP 2021-087 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan Potassium USP
    Issue/Submission Date
    2020-09-01
    2022-11-17
    2022-09-19
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    Oxcarbazepine

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    USDMF

    Found USDMF

    34484
    Active
    OXCARBAZEPINE USP
    2019-12-31
    CEP/COS

    Found CEP/COS

    CEP 2022-155 - Rev 00
    Valid
    Oxcarbazepine
    2023-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Oxcarbazepine
    2022-09-19
    Application Number
    34484
    CEP 2022-155 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    OXCARBAZEPINE USP
    Oxcarbazepine
    Oxcarbazepine
    Issue/Submission Date
    2019-12-31
    2023-09-12
    2022-09-19
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    • FDA
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    Valacyclovir Hydrochloride

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    USDMF

    Found USDMF

    34743
    Active
    VALACYCLOVIR HYDROCHLORIDE USP
    2020-03-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-123 - Rev 00
    Valid
    Valaciclovir hydrochloride
    2022-10-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Valaciclovir Hydrochloride Ph.Eur/B...
    2022-09-19
    Application Number
    34743
    R0-CEP 2022-123 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE USP
    Valaciclovir hydrochloride
    Valaciclovir Hydrochloride Ph.Eur/B...
    Issue/Submission Date
    2020-03-20
    2022-10-24
    2022-09-19
    ASK
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    • FDA
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    Verapamil Hydrochloride

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    See Less

    USDMF

    Found USDMF

    34043
    Active
    VERAPAMIL HYDROCHLORIDE USP
    2019-07-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-172 - Rev 00
    Valid
    Verapamil hydrochloride
    2021-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Verapamil Hydrochloride USP/Ph Eur
    2022-09-19
    Application Number
    34043
    R0-CEP 2019-172 - Rev 00
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VERAPAMIL HYDROCHLORIDE USP
    Verapamil hydrochloride
    Verapamil Hydrochloride USP/Ph Eur
    Issue/Submission Date
    2019-07-31
    2021-09-09
    2022-09-19
    ASK
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    • FDA
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    Aciclovir

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36328
    Active
    ACYCLOVIR USP [SITE KHAZIPALLY]
    2021-09-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-274 - Rev 00
    Valid
    Aciclovir, Site Khazipally
    2021-10-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A9
    Expired
    Acyclovir USP, Ph.Eur
    2020-09-30
    Application Number
    36328
    R0-CEP 2021-274 - Rev 00
    Indian CDSCO WC-0119A9
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ACYCLOVIR USP [SITE KHAZIPALLY]
    Aciclovir, Site Khazipally
    Acyclovir USP, Ph.Eur
    Issue/Submission Date
    2021-09-29
    2021-10-07
    2020-09-30
    ASK
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    Levetiracetam

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    35272
    Active
    LEVETIRACETAM FORM-I USP
    2020-10-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-196 - Rev 00
    Valid
    Levetiracetam, Form I
    2021-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A6
    Expired
    Levetiracetam Ph.Eur/BP/USP
    2020-08-07
    Application Number
    35272
    R0-CEP 2021-196 - Rev 00
    Indian CDSCO WC-0119A6
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LEVETIRACETAM FORM-I USP
    Levetiracetam, Form I
    Levetiracetam Ph.Eur/BP/USP
    Issue/Submission Date
    2020-10-12
    2021-07-13
    2020-08-07
    ASK
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    • FDA
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    Valacyclovir Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    36202
    Active
    VALACYCLOVIR HYDROCHLORIDE USP
    2021-08-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-059 - Rev 01
    Valid
    Valaciclovir hydrochloride hydrate
    2022-02-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A6
    Expired
    Valaciclovir Hydrochloride Ph.Eur/B...
    2020-08-07
    Application Number
    36202
    R0-CEP 2020-059 - Rev 01
    Indian CDSCO WC-0119A6
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE USP
    Valaciclovir hydrochloride hydrate
    Valaciclovir Hydrochloride Ph.Eur/B...
    Issue/Submission Date
    2021-08-20
    2022-02-17
    2020-08-07
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    • FDA
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    Desvenlafaxine Succinate

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    USDMF

    Found USDMF

    34429
    Active
    DESVENLAFAXINE SUCCINATE USP
    2019-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Desvenlafaxine Succinate IH
    2022-09-19
    Application Number
    34429
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    DESVENLAFAXINE SUCCINATE USP
    Desvenlafaxine Succinate IH
    Issue/Submission Date
    2019-12-19
    2022-09-19
    ASK
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    • FDA
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    Fluphenazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35695
    Active
    FLUPHENAZINE HYDROCHLORIDE USP
    2021-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Fluphenazine Hydrochloride USP
    2022-09-19
    Application Number
    35695
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    FLUPHENAZINE HYDROCHLORIDE USP
    Fluphenazine Hydrochloride USP
    Issue/Submission Date
    2021-03-27
    2022-09-19
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    Marbofloxacin

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    USDMF

    Found USDMF

    35484
    Active
    MARBOFLOXACIN
    2020-12-31
    CEP/COS

    Found CEP/COS

    CEP 2021-449 - Rev 00
    Valid
    Marbofloxacin for veterinary use
    2023-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35484
    CEP 2021-449 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MARBOFLOXACIN
    Marbofloxacin for veterinary use
    Issue/Submission Date
    2020-12-31
    2023-12-19
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    • FDA
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    Molnupiravir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36329
    Active
    MOLNUPIRAVIR
    2021-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Molnupiravir lH
    2022-09-19
    Application Number
    36329
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    MOLNUPIRAVIR
    Molnupiravir lH
    Issue/Submission Date
    2021-09-30
    2022-09-19
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    Prazosin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35486
    Active
    PRAZOSIN HYDROCHLORIDE USP
    2020-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Prazosin Hydrochloride USP
    2022-09-19
    Application Number
    35486
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    PRAZOSIN HYDROCHLORIDE USP
    Prazosin Hydrochloride USP
    Issue/Submission Date
    2020-12-31
    2022-09-19
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    Raloxifene Hydrochloride

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    USDMF

    Found USDMF

    36445
    Active
    RALOXIFENE HYDROCHLORIDE USP
    2021-10-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Raloxefene hydrochloride Ph.Eur/USP
    2022-09-19
    Application Number
    36445
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    RALOXIFENE HYDROCHLORIDE USP
    Raloxefene hydrochloride Ph.Eur/USP
    Issue/Submission Date
    2021-10-23
    2022-09-19
    ASK
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    Salsalate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    34515
    Active
    SALSALATE USP
    2020-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Salsalate USP
    2022-09-19
    Application Number
    34515
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    SALSALATE USP
    Salsalate USP
    Issue/Submission Date
    2020-01-29
    2022-09-19
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    Sulindac

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36760
    Active
    SULINDAC
    2022-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Sulindac IHS
    2022-09-19
    Application Number
    36760
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    SULINDAC
    Sulindac IHS
    Issue/Submission Date
    2022-02-03
    2022-09-19
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    Tofacitinib Citrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35844
    Active
    TOFACITINIB CITRATE
    2021-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Tofacitinib Citrate IH
    2022-09-19
    Application Number
    35844
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TOFACITINIB CITRATE
    Tofacitinib Citrate IH
    Issue/Submission Date
    2021-04-26
    2022-09-19
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    Tolvaptan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34379
    Active
    TOLVAPTAN
    2019-12-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Tolvaptan
    2022-09-19
    Application Number
    34379
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TOLVAPTAN
    Tolvaptan
    Issue/Submission Date
    2019-12-05
    2022-09-19
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    Valganciclovir Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34600
    Active
    VALGANCICLOVIR HYDROCHLORIDE USP
    2020-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0119
    Valid
    Valganciclovir HCl USP
    2022-09-19
    Application Number
    34600
    Indian CDSCO WC-0119
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    VALGANCICLOVIR HYDROCHLORIDE USP
    Valganciclovir HCl USP
    Issue/Submission Date
    2020-02-26
    2022-09-19
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    Amlodipine Besylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2023-064 - Rev 00
    Valid
    Amlodipine besilate, Site Khazipall...
    2023-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A6
    Expired
    Amlodipine Besilate Ph.Eur/BP/USP
    2020-08-07
    Application Number
    R0-CEP 2023-064 - Rev 00
    Indian CDSCO WC-0119A6
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Amlodipine besilate, Site Khazipall...
    Amlodipine Besilate Ph.Eur/BP/USP
    Issue/Submission Date
    2023-05-31
    2020-08-07
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    Favipiravir

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35680
    Active
    FAVIPIRAVIR
    2021-03-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A10
    Expired
    Favipiravir IH
    2021-10-13
    Application Number
    35680
    Indian CDSCO WC-0119A10
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    FAVIPIRAVIR
    Favipiravir IH
    Issue/Submission Date
    2021-03-22
    2021-10-13
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    Levothyroxine Sodium

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-295 - Rev 00
    Valid
    Levothyroxine sodium, LIM code
    2023-12-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A6
    Expired
    Levothyroxine Sodium USP/EP
    2020-08-07
    Application Number
    CEP 2023-295 - Rev 00
    Indian CDSCO WC-0119A6
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Levothyroxine sodium, LIM code
    Levothyroxine Sodium USP/EP
    Issue/Submission Date
    2023-12-11
    2020-08-07
    ASK
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    Tolvaptan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34381
    Active
    TOLVAPTAN AMORPHOUS
    2019-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0119A6
    Expired
    Tolvaptan IH
    2020-08-07
    Application Number
    34381
    Indian CDSCO WC-0119A6
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    TOLVAPTAN AMORPHOUS
    Tolvaptan IH
    Issue/Submission Date
    2019-11-30
    2020-08-07
    ASK
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    Aripiprazole

    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-0119
    Valid
    Aripiprazole Ph.Eur/USP
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Aripiprazole Ph.Eur/USP
    Issue/Submission Date
    2022-09-19
    ASK
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    Armodafinil

    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-0119
    Valid
    Armodafinil IH
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Armodafinil IH
    Issue/Submission Date
    2022-09-19
    ASK
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    Bilastine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    39005
    Active
    BILASTINE (FORM-I)
    2023-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39005
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BILASTINE (FORM-I)
    Issue/Submission Date
    2023-10-10
    ASK
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    Camostat

    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-0119
    Valid
    Camostat Mesilate JP
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Camostat Mesilate JP
    Issue/Submission Date
    2022-09-19
    ASK
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    Celecoxib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2023-194 - Rev 00
    Valid
    Celecoxib, Site Khazipally
    2023-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2023-194 - Rev 00
    Status
    Valid
     
    Filing Details
    Celecoxib, Site Khazipally
    Issue/Submission Date
    2023-08-16
    ASK
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    Citalopram Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    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-0119
    Valid
    Citalopram Hydrochloride Ph.Eur
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Citalopram Hydrochloride Ph.Eur
    Issue/Submission Date
    2022-09-19
    ASK
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    • FDA
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    Dabigatran Etexilate Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37002
    Active
    DABIGATRAN ETEXILATE MESILATE
    2022-04-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37002
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DABIGATRAN ETEXILATE MESILATE
    Issue/Submission Date
    2022-04-06
    ASK
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    Dolutegravir Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    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-0119
    Valid
    Dolutegravir sodium IH
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Dolutegravir sodium IH
    Issue/Submission Date
    2022-09-19
    ASK
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    Erdosteine

    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-0119
    Valid
    Erdosteine IH
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Erdosteine IH
    Issue/Submission Date
    2022-09-19
    ASK
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    Esomeprazole Magnesium

    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-0119
    Valid
    Esomeprazole Magnesium
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Esomeprazole Magnesium
    Issue/Submission Date
    2022-09-19
    ASK
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    Etoricoxib

    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-0119
    Valid
    Etoricoxib
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Etoricoxib
    Issue/Submission Date
    2022-09-19
    ASK
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    Favipiravir

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

    See Less

    USDMF

    Found USDMF

    36510
    Active
    FAVIPIRAVIR [Route Code- FRR]
    2021-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36510
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FAVIPIRAVIR [Route Code- FRR]
    Issue/Submission Date
    2021-11-15
    ASK
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    Fesoterodine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35679
    Active
    FESOTERODINE FUMARATE
    2021-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35679
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2021-03-05
    ASK
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    Flecainide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-410 - Rev 00
    Valid
    Flecainide acetate
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-410 - Rev 00
    Status
    Valid
     
    Filing Details
    Flecainide acetate
    Issue/Submission Date
    2024-03-11
    ASK
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    Indomethacin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36761
    Active
    INDOMETHACIN USP
    2022-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36761
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    INDOMETHACIN USP
    Issue/Submission Date
    2022-02-03
    ASK
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    Mirtazapine

    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-0119
    Valid
    Mitrazapine Ph.Eur
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Mitrazapine Ph.Eur
    Issue/Submission Date
    2022-09-19
    ASK
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    • FDA
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    Nafamostat

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36046
    Active
    NAFAMOSTAT MESILATE JP
    2021-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36046
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NAFAMOSTAT MESILATE JP
    Issue/Submission Date
    2021-07-03
    ASK
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    Pinaverium Bromide

    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-0119
    Valid
    Pinaverium Bromide IH
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Pinaverium Bromide IH
    Issue/Submission Date
    2022-09-19
    ASK
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    Tafamidis

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37480
    Active
    TAFAMIDIS
    2022-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37480
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TAFAMIDIS
    Issue/Submission Date
    2022-10-18
    ASK
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    Tafamidis Meglumine

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

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    USDMF

    Found USDMF

    37152
    Active
    TAFAMIDIS MEGLUMINE
    2022-06-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37152
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TAFAMIDIS MEGLUMINE
    Issue/Submission Date
    2022-06-03
    ASK
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    • FDA
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    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-0119
    Valid
    Venlafaxine Hydrochloride (Ph. Eur....
    2022-09-19
    Application Number
    Indian CDSCO WC-0119
    Status
     
    Valid
    2025-07-02
    Filing Details
    Venlafaxine Hydrochloride (Ph. Eur....
    Issue/Submission Date
    2022-09-19
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