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

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    RUSAN PHARMA

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    APIs // Active Pharmaceutical Ingredients

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    Key Products KEY PRODUCTS

    • Apomorphine Hydrochloride

    • Clonazepam

    • Eflornithine Hydrochloride

    • Nalbuphine Hydrochloride

    • Sodium Oxybate

    SERVICES

    Key Products KEY SERVICES

    • Bioanalytical Method Development & Validation

    • Bioanalytical - Pharmacokinetic Modeling

    • Clinical Trial Monitoring

    • Clinical Data Management

    • Statistical Analysis for Clinical Trials

    • Medical Writing for Clinical Trials

    • Patient Recruitment for Clinical Trials

    • Investigator Selection for Clinical Trials

    • Quality Assurance & Compliance

    • In-vitro & In-vivo Bioequivalence Studies

    INSPECTIONS & REGISTRATIONS

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    Rusan Pharma
    Rusan Pharma
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    Country
    India
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    Address
    58-D, Government Industrial Estate, Charkop, Kandivali (West), Mumbai – 400 067 Maharashtra
    Telephone
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    +91 02242383000
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    enquiry@rusanpharma.com
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    http://www.rusanpharma.com/
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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Apomorphine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Apomorphine HCl USP/BP at Plot No. ...
    2021-08-27
    Application Number
    CEP 2021-135 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Expired
    2024-06-10
    Filing Details
    Apomorphine hydrochloride hemihydra...
    Apomorphine HCl USP/BP at Plot No. ...
    Issue/Submission Date
    2024-02-14
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    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

    Close JDMF

    Written Confirmation

    Caution WC

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

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    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

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Buprenorphine EP/BP at Plot No. 640...
    2021-08-27
    Application Number
    R1-CEP 2015-387 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Expired
    2024-06-10
    Filing Details
    Buprenorphine
    Buprenorphine EP/BP at Plot No. 640...
    Issue/Submission Date
    2022-11-14
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    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

    Caution WC

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

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Eflornithine Hydrochloride

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    USDMF

    Found USDMF

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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Eflornithine Hydrochloride Monohydr...
    2021-08-27
    Application Number
    31780
    Indian CDSCO WC-0278A2n
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    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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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Fentanyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Fentanyl EP/BP at Plot No. 6406, GI...
    2021-08-27
    Application Number
    R1-CEP 2016-018 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Expired
    2024-06-10
    Filing Details
    Fentanyl
    Fentanyl EP/BP at Plot No. 6406, GI...
    Issue/Submission Date
    2022-05-20
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Fentanyl Citrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Caution WC

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

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    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

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Nalmefene HCl IH at Plot No. 6406, ...
    2021-08-27
    Application Number
    34367
    Indian CDSCO WC-0278A2n
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2024-06-10
    Filing Details
    NALMEFENE HYDROCHLORIDE
    Nalmefene HCl IH at Plot No. 6406, ...
    Issue/Submission Date
    2019-12-13
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Naltrexone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Naltrexone Hcl EP/USP at Plot No. 6...
    2021-08-27
    Application Number
    R1-CEP 2016-053 - Rev 00
    Indian CDSCO WC-0278A2n
    Status
    Valid
     
    Expired
    2024-06-10
    Filing Details
    Naltrexone hydrochloride
    Naltrexone Hcl EP/USP at Plot No. 6...
    Issue/Submission Date
    2023-01-13
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Methadone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Methadone Hydrochloride EP/BP/USP a...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Methadone Hydrochloride EP/BP/USP a...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Nalbuphine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Nalbuphine HCL IH at Plot No. 6406,...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Nalbuphine HCL IH at Plot No. 6406,...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Naloxone Hydrochloride

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Naloxone HCl EP/BP/USP at Plot No. ...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Naloxone HCl EP/BP/USP at Plot No. ...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Naltrexone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Naltrexone Base IH at Plot No. 6406...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Naltrexone Base IH at Plot No. 6406...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Promedol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Promedol Hydrochloride IH at Plot ...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Promedol Hydrochloride IH at Plot ...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    • FDA
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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Sodium Oxybate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0278A2n
    Expired
    Sodium Oxybate at Plot No. 6406, GI...
    2021-08-27
    Application Number
    Indian CDSCO WC-0278A2n
    Status
     
    Expired
    2024-06-10
    Filing Details
    Sodium Oxybate at Plot No. 6406, GI...
    Issue/Submission Date
    2021-08-27
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Alfentanil Hydrochloride

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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
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Carbamazepine

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Clonazepam

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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
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Diazepam

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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
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Dihydrocodeine Hydrogen Tartrate

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Hydrocodone Bitartrate

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Hydromorphone Hydrochloride

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Methylnaltrexone Bromide

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Midazolam

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    n-Butyl Cyanoacrylate

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    Application Number
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    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

    Nitrazepam

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    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Rusan Pharma

    CPhI Worldwide, Milan

    Booth #22D92

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    Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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