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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Rusan Pharma Ltd

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    01 Apomorphine Hydrochloride (2)

    02 Bisoprolol Fumarate (2)

    03 Buprenorphine (2)

    04 Buprenorphine Hydrochloride (2)

    05 Eflornithine (2)

    06 Fentanyl (2)

    07 Fentanyl Citrate (2)

    08 Loperamide Hydrochloride (1)

    09 Methadone Hydrochloride (1)

    10 Methylnaltrexone Bromide (1)

    11 Nalbuphine (2)

    12 Nalmefene Hydrochloride (1)

    13 Naloxone Hydrochloride (2)

    14 Naltrexone (2)

    15 Naltrexone Hydrochloride (2)

    16 Pregabalin (1)

    17 Sodium Oxybate (1)

    18 Trimeperidine Hydrochloride (2)

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    01 Active (2)

    02 Blank (28)

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    01 Valid (8)

    02 Blank (22)

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    01 Blank (30)

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    01 WC-0278 (12)

    02 WC-0278A2n (15)

    03 Blank (3)

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    Apomorphine Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2021-135 - Rev 00
    Valid
    Apomorphine hydrochloride hemihydra...
    2024-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Apomorphine HCl USP/BP
    2021-08-27
    Application Number
    CEP 2021-135 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Apomorphine hydrochloride hemihydra...
    Apomorphine HCl USP/BP
    Issue/Submission Date
    2024-02-14
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Bisoprolol Fumarate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2020-095 - Rev 00
    Valid
    Bisoprolol fumarate
    2022-05-04
    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Bisoprolol Fumarate EP/BP/USP
    2021-08-27
    Application Number
    R0-CEP 2020-095 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Bisoprolol fumarate
    Bisoprolol Fumarate EP/BP/USP
    Issue/Submission Date
    2022-05-04
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Buprenorphine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-387 - Rev 00
    Valid
    Buprenorphine
    2022-11-14
    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Buprenorphine EP/BP
    2021-08-27
    Application Number
    R1-CEP 2015-387 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Buprenorphine
    Buprenorphine EP/BP
    Issue/Submission Date
    2022-11-14
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Buprenorphine Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2017-228 - Rev 00
    Valid
    Buprenorphine hydrochloride
    2023-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Buprenorphine Hydrochloride EP/BP
    2021-08-27
    Application Number
    R1-CEP 2017-228 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Buprenorphine hydrochloride
    Buprenorphine Hydrochloride EP/BP
    Issue/Submission Date
    2023-01-23
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Eflornithine

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    USDMF

    Found USDMF

    31780
    Active
    EFLORNITHINE HYDROCHLORIDE MONOHYDR...
    2017-06-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Eflornithine Hydrochloride Monohydr...
    2021-08-27
    Application Number
    31780
    Indian CDSCO WC-0278A2n
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2024-06-10
    Filing Details
    EFLORNITHINE HYDROCHLORIDE MONOHYDR...
    Eflornithine Hydrochloride Monohydr...
    Issue/Submission Date
    2017-06-29
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Fentanyl

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2016-018 - Rev 00
    Valid
    Fentanyl
    2022-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Fentanyl EP/BP
    2021-08-27
    Application Number
    R1-CEP 2016-018 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Fentanyl
    Fentanyl EP/BP
    Issue/Submission Date
    2022-05-20
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Fentanyl Citrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2016-023 - Rev 00
    Valid
    Fentanyl citrate
    2022-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Fentanyl Citrate EP/BP/USP
    2021-08-27
    Application Number
    R1-CEP 2016-023 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Fentanyl citrate
    Fentanyl Citrate EP/BP/USP
    Issue/Submission Date
    2022-05-30
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Methadone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2017-277 - Rev 02
    Valid
    Methadone hydrochloride
    2022-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Methadone Hydrochloride EP/BP/USP
    2021-08-27
    Application Number
    R0-CEP 2017-277 - Rev 02
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Methadone hydrochloride
    Methadone Hydrochloride EP/BP/USP
    Issue/Submission Date
    2022-10-28
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Nalmefene Hydrochloride

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    USDMF

    Found USDMF

    34367
    Active
    NALMEFENE HYDROCHLORIDE
    2019-12-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Nalmefene HCl IH
    2021-08-27
    Application Number
    34367
    Indian CDSCO WC-0278A2n
    Status
    Active
    Fees Unpaid
    N/A
     
    Valid
    2024-06-10
    Filing Details
    NALMEFENE HYDROCHLORIDE
    Nalmefene HCl IH
    Issue/Submission Date
    2019-12-13
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Naltrexone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2016-053 - Rev 00
    Valid
    Naltrexone hydrochloride
    2023-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0278A2n
    Valid
    Naltrexone Hcl EP/USP
    2021-08-27
    Application Number
    R1-CEP 2016-053 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Valid
    2024-06-10
    Filing Details
    Naltrexone hydrochloride
    Naltrexone Hcl EP/USP
    Issue/Submission Date
    2023-01-13
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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