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

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    Kopran
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    Country
    Country
    India
    Address
    Address
    Parijat House, 1076, Dr. E. Moses Road, Worli, Mumbai - 400 018, Maharashtra
    Telephone
    Telephone
    +91-22-43661111
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.kopran.com/
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    Atenolol

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    USDMF

    Found USDMF

    33007
    Active
    ATENOLOL USP
    2018-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-017 - Rev 06
    Valid
    Atenolol
    2021-03-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0090A3
    Expired
    Atenolol USP
    2021-10-05
    Application Number
    33007
    R1-CEP 1998-017 - Rev 06
    Indian CDSCO WC-0090A3
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-14
    Filing Details
    ATENOLOL USP
    Atenolol
    Atenolol USP
    Issue/Submission Date
    2018-07-27
    2021-03-12
    2021-10-05
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    Atenolol

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    USDMF

    Caution USDMF

    25010
    Inactive
    ATENOLOL
    2011-05-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-479 - Rev 00
    Valid
    Atenolol, ALA route
    2022-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Atenolol (EP)
    2022-08-31
    Application Number
    25010
    R0-CEP 2021-479 - Rev 00
    Indian CDSCO WC-0090
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    ATENOLOL
    Atenolol, ALA route
    Atenolol (EP)
    Issue/Submission Date
    2011-05-20
    2022-07-27
    2022-08-31
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    Pregabalin

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    USDMF

    Caution USDMF

    26062
    Inactive
    PREGABALIN
    2012-05-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-080 - Rev 02
    Valid
    Pregabalin
    2022-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Pregabalin (IH)
    2022-08-31
    Application Number
    26062
    R0-CEP 2018-080 - Rev 02
    Indian CDSCO WC-0090
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-07-14
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin (IH)
    Issue/Submission Date
    2012-05-02
    2022-09-16
    2022-08-31
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    Azithromycin Dihydrate

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    USDMF

    Found USDMF

    34853
    Active
    AZITHROMYCIN DIHYDRATE USP
    2020-05-21
    CEP/COS

    Found CEP/COS

    CEP 2005-230 - Rev 03
    Valid
    Azithromycin, Dihydrate
    2024-04-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34853
    CEP 2005-230 - Rev 03
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AZITHROMYCIN DIHYDRATE USP
    Azithromycin, Dihydrate
    Issue/Submission Date
    2020-05-21
    2024-04-02
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    Roxithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-309 - Rev 03
    Valid
    Roxithromycin
    2021-02-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Roxithromycin (EP)
    2022-08-31
    Application Number
    R1-CEP 2001-309 - Rev 03
    Indian CDSCO WC-0090
    Status
    Valid
     
    Valid
    2025-07-14
    Filing Details
    Roxithromycin
    Roxithromycin (EP)
    Issue/Submission Date
    2021-02-17
    2022-08-31
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    Cefotaxime

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-223 - Rev 01
    Withdrawn by Holder
    Cefotaxime sodium
    2006-11-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Cefotaxime Sodium (EP/USP)
    2022-08-31
    Application Number
    R0-CEP 2001-223 - Rev 01
    Indian CDSCO WC-0090
    Status
    Withdrawn by Holder
     
    Valid
    2025-07-14
    Filing Details
    Cefotaxime sodium
    Cefotaxime Sodium (EP/USP)
    Issue/Submission Date
    2006-11-06
    2022-08-31
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    Ceftriaxone

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-222 - Rev 02
    Expired
    Ceftriaxone sodium
    2005-08-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Ceftriaxone Sodium (USP)
    2022-08-31
    Application Number
    R0-CEP 2001-222 - Rev 02
    Indian CDSCO WC-0090
    Status
    Expired
     
    Valid
    2025-07-14
    Filing Details
    Ceftriaxone sodium
    Ceftriaxone Sodium (USP)
    Issue/Submission Date
    2005-08-22
    2022-08-31
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Azithromycin (EP)
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Azithromycin (EP)
    Issue/Submission Date
    2022-08-31
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    Cefepime

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Cefepime for Injection (USP)
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Cefepime for Injection (USP)
    Issue/Submission Date
    2022-08-31
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    Meropenem

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Meropenem For Injection USP
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Meropenem For Injection USP
    Issue/Submission Date
    2022-08-31
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    35110
    Active
    METOPROLOL SUCCINATE
    2020-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35110
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    METOPROLOL SUCCINATE
    Issue/Submission Date
    2020-08-20
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    Metoprolol Tartrate

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    USDMF

    Found USDMF

    34903
    Active
    METOPROLOL TARTRATE USP
    2020-05-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34903
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    METOPROLOL TARTRATE USP
    Issue/Submission Date
    2020-05-30
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    Nitroxinil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0090
    Valid
    Nitroxoline
    2022-08-31
    Application Number
    Indian CDSCO WC-0090
    Status
     
    Valid
    2025-07-14
    Filing Details
    Nitroxoline
    Issue/Submission Date
    2022-08-31
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    Pregabalin

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    USDMF

    Found USDMF

    34852
    Active
    PREGBALIN USP
    2020-05-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34852
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PREGBALIN USP
    Issue/Submission Date
    2020-05-13
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    8845
    Inactive
    AMOXYCILLIN TRIHYDRATE
    1990-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8845
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AMOXYCILLIN TRIHYDRATE
    Issue/Submission Date
    1990-11-15
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    Ampicillin Trihydrate

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    USDMF

    Caution USDMF

    8843
    Inactive
    AMPICILLIN TRIHYDRATE
    1990-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8843
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Issue/Submission Date
    1990-11-15
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    Biapenem

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    USDMF

    Caution USDMF

    34914
    Inactive
    BIAPENEM STERILE
    2020-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34914
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BIAPENEM STERILE
    Issue/Submission Date
    2020-06-16
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    Cloxacillin Sodium

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    USDMF

    Caution USDMF

    8844
    Inactive
    CLOXACILLIN SODIUM
    1990-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8844
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CLOXACILLIN SODIUM
    Issue/Submission Date
    1990-11-15
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    Doripenem

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    34913
    Inactive
    DORIPENEM STERILE
    2020-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34913
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DORIPENEM STERILE
    Issue/Submission Date
    2020-06-16
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    FACILITIES AND OPERATIONS IN MAHARASHTRA, INDIA

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    USDMF

    Caution USDMF

    8846
    Inactive
    FACILITIES AND OPERATIONS IN MAHARA...
    1990-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8846
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FACILITIES AND OPERATIONS IN MAHARA...
    Issue/Submission Date
    1990-11-15
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    Amlodipine Besylate

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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
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    Apixaban

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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
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    Canagliflozin

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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
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    Clarithromycin

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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
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    Dapagliflozin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Empagliflozin

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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
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    Ertapenem Sodium

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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
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    Faropenem

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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
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    Imipenem

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
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    Lymecycline

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Rivaroxaban

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
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    Tebipenem Pivoxil Hydrobromide

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