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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hubei Biocause Heilen Pharmaceutical Co., Ltd

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    HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD

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    Hubei Biocause Heilen Pharmaceutical Co., Ltd
    China Flag
    Country
    Country
    China
    Address
    Address
    C-7th Floor, Golden trade center, Guantong Garden, 115 Wujiadun Road, Jianghan District, Wuhan 430023 Hubei
    Telephone
    Telephone
    +86 27 65651730
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.biocause.com/
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    Linkedin
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    Fludarabine Phosphate

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    USDMF

    Found USDMF

    21047
    Active
    Fludarabine Phosphate Drug Substanc...
    2007-11-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-136 - Rev 01
    Valid
    Fludarabine phosphate
    2022-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21047
    R0-CEP 2020-136 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    Fludarabine Phosphate Drug Substanc...
    Fludarabine phosphate
    Issue/Submission Date
    2007-11-12
    2022-01-25
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    19078
    Active
    GRANISETRON HYDROCHLORIDE, NON-STER...
    2005-12-15
    CEP/COS

    Found CEP/COS

    CEP 2008-184 - Rev 02
    Valid
    Granisetron hydrochloride
    2024-02-27
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19078
    CEP 2008-184 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GRANISETRON HYDROCHLORIDE, NON-STER...
    Granisetron hydrochloride
    Issue/Submission Date
    2005-12-15
    2024-02-27
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    • FDA
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    Ibuprofen

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    USDMF

    Found USDMF

    15839
    Active
    IBUPROFEN USP
    2002-01-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-099 - Rev 07
    Valid
    Ibuprofen
    2020-12-07
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    15839
    R1-CEP 2002-099 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IBUPROFEN USP
    Ibuprofen
    Issue/Submission Date
    2002-01-25
    2020-12-07
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    Fludarabine Phosphate

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    USDMF

    Found USDMF

    34509
    Active
    FLUDARABINE PHOSPHATE DRUG SUBSTANC...
    2020-04-29
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-311 - Rev 00
    Withdrawn by Holder
    Fludarabine phosphate
    2014-06-18
    Japanese DMF

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    Written Confirmation

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    Application Number
    34509
    R1-CEP 2007-311 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    FLUDARABINE PHOSPHATE DRUG SUBSTANC...
    Fludarabine phosphate
    Issue/Submission Date
    2020-04-29
    2014-06-18
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    Abiraterone Acetate

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    USDMF

    Found USDMF

    27853
    Active
    ABIRATERONE ACETATE
    2013-12-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    27853
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABIRATERONE ACETATE
    Issue/Submission Date
    2013-12-24
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    Atropine Sulfate

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    USDMF

    Found USDMF

    28978
    Active
    ATROPINE SULFATE
    2014-12-25
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28978
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ATROPINE SULFATE
    Issue/Submission Date
    2014-12-25
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    Cladribine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-104 - Rev 00
    Valid
    Cladribine
    2024-04-22
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2023-104 - Rev 00
    Status
    Valid
     
    Filing Details
    Cladribine
    Issue/Submission Date
    2024-04-22
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    35455
    Active
    DEXMEDETOMIDINE DRUG SUBSTANCE
    2021-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    35455
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEXMEDETOMIDINE DRUG SUBSTANCE
    Issue/Submission Date
    2021-08-23
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    • FDA
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    Flumazenil

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    USDMF

    Found USDMF

    19723
    Active
    FLUMAZENIL
    2006-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    19723
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUMAZENIL
    Issue/Submission Date
    2006-08-31
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    • FDA
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    Homatropine Hydrobromide

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    USDMF

    Found USDMF

    34161
    Active
    HOMATROPINE HYDROBROMIDE
    2019-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    34161
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HOMATROPINE HYDROBROMIDE
    Issue/Submission Date
    2019-09-29
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    Homatropine Methylbromide

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    USDMF

    Found USDMF

    28530
    Active
    HOMATROPINE METHYLBROMIDE
    2014-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    28530
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HOMATROPINE METHYLBROMIDE
    Issue/Submission Date
    2014-07-28
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    • FDA
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    Hyoscyamine Sulfate

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    USDMF

    Found USDMF

    28614
    Active
    HYOSCYAMINE SULFATE
    2014-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    28614
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYOSCYAMINE SULFATE
    Issue/Submission Date
    2014-09-02
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35370
    Active
    DEXIBUPROFEN DRUG SUBSTANCE
    2020-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35370
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEXIBUPROFEN DRUG SUBSTANCE
    Issue/Submission Date
    2020-11-09
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    • FDA
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    Milrinone

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    USDMF

    Found USDMF

    19726
    Active
    MILRINONE
    2006-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19726
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MILRINONE
    Issue/Submission Date
    2006-08-31
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    • FDA
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    Torsemide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-088 - Rev 02
    Valid
    Torasemide
    2019-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-088 - Rev 02
    Status
    Valid
     
    Filing Details
    Torasemide
    Issue/Submission Date
    2019-04-05
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