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

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    Desmopressin Acetate

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    USDMF

    Found USDMF

    31889
    Active
    DESMOPRESSIN ACETATE
    2017-07-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-221 - Rev 00
    Valid
    Desmopressin
    2022-11-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    31889
    R0-CEP 2021-221 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DESMOPRESSIN ACETATE
    Desmopressin
    Issue/Submission Date
    2017-07-28
    2022-11-14
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    Ganirelix

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    USDMF

    Found USDMF

    30800
    Active
    GANIRELIX ACETATE NON-STERILE BULK ...
    2016-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10067
    Ganirelix Acetate at Hybio Medicine...
    2018-05-31
    Written Confirmation

    Close WC

    Application Number
    30800
    230MF10067
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GANIRELIX ACETATE NON-STERILE BULK ...
    Ganirelix Acetate at Hybio Medicine...
    Issue/Submission Date
    2016-07-28
    2018-05-31
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    Oxytocin

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    USDMF

    Found USDMF

    34916
    Active
    OXYTOCIN NON STERILE BULK DRUG SUBS...
    2020-07-20
    CEP/COS

    Found CEP/COS

    CEP 2020-322 - Rev 01
    Valid
    Oxytocin
    2024-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34916
    CEP 2020-322 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXYTOCIN NON STERILE BULK DRUG SUBS...
    Oxytocin
    Issue/Submission Date
    2020-07-20
    2024-01-17
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    37082
    Active
    CETRORELIX ACETATE, NON-STERILE DRU...
    2022-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    37082
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CETRORELIX ACETATE, NON-STERILE DRU...
    Issue/Submission Date
    2022-04-29
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    Eptifibatide

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    USDMF

    Found USDMF

    26453
    Active
    EPTIFIBATIDE ACETATE, NON-STERILE B...
    2012-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26453
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPTIFIBATIDE ACETATE, NON-STERILE B...
    Issue/Submission Date
    2012-09-20
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    Glatiramer Acetate

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    USDMF

    Found USDMF

    28989
    Active
    GLATIRAMER ACETATE, NON-STERILE BUL...
    2014-12-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    28989
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLATIRAMER ACETATE, NON-STERILE BUL...
    Issue/Submission Date
    2014-12-25
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    Leuprolide Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-016 - Rev 00
    Valid
    Leuprorelin
    2020-04-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-016 - Rev 00
    Status
    Valid
     
    Filing Details
    Leuprorelin
    Issue/Submission Date
    2020-04-23
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    Linaclotide

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    USDMF

    Found USDMF

    32314
    Active
    LINACLOTIDE (NON-STERILE BULK DRUG ...
    2017-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32314
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LINACLOTIDE (NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2017-12-28
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    Linaclotide

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    USDMF

    Found USDMF

    37370
    Active
    LINACLOTIDE NON-STERILE DRUG SUBSTA...
    2022-08-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37370
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LINACLOTIDE NON-STERILE DRUG SUBSTA...
    Issue/Submission Date
    2022-08-17
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    Liraglutide

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    USDMF

    Found USDMF

    30095
    Active
    LIRAGLUTIDE NON-STERILE BULK DRUG S...
    2015-12-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30095
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LIRAGLUTIDE NON-STERILE BULK DRUG S...
    Issue/Submission Date
    2015-12-07
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    Liraglutide

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    USDMF

    Found USDMF

    35364
    Active
    LIRAGLUTIDE, NON-STERILE BULK DRUG ...
    2020-11-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35364
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LIRAGLUTIDE, NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2020-11-27
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    Natriuretic Peptide, Brain

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    USDMF

    Found USDMF

    27265
    Active
    NESIRITIDE CITRATE, NON-STERILE BUL...
    2013-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27265
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NESIRITIDE CITRATE, NON-STERILE BUL...
    Issue/Submission Date
    2013-06-25
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    Octreotide Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-253 - Rev 00
    Valid
    Octreotide
    2022-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-253 - Rev 00
    Status
    Valid
     
    Filing Details
    Octreotide
    Issue/Submission Date
    2022-03-14
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    Semaglutide

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    USDMF

    Found USDMF

    38443
    Active
    SEMAGLUTIDE, NON-STERILE DRUG SUBST...
    2023-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38443
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SEMAGLUTIDE, NON-STERILE DRUG SUBST...
    Issue/Submission Date
    2023-06-09
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    Teriparatide

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    USDMF

    Found USDMF

    34388
    Active
    TERIPARATIDE, NON-STERILE BULK DRUG...
    2019-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34388
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TERIPARATIDE, NON-STERILE BULK DRUG...
    Issue/Submission Date
    2019-12-31
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    Teriparatide

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    USDMF

    Found USDMF

    36502
    Active
    TERIPARATIDE, NON STERILE BULK DRUG...
    2021-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36502
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERIPARATIDE, NON STERILE BULK DRUG...
    Issue/Submission Date
    2021-12-29
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    Terlipressin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-319 - Rev 00
    Valid
    Terlipressin
    2021-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-319 - Rev 00
    Status
    Valid
     
    Filing Details
    Terlipressin
    Issue/Submission Date
    2021-10-28
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    DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE

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    USDMF

    Found USDMF

    38904
    Active
    DEGARELIX ACETATE, NON-STERILE DRUG...
    2023-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38904
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEGARELIX ACETATE, NON-STERILE DRUG...
    Issue/Submission Date
    2023-09-27
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    CANNABIDIOL NON-STERILE DRUG SUBSTANCE

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    USDMF

    Found USDMF

    39222
    Active
    CANNABIDIOL NON-STERILE DRUG SUBSTA...
    2023-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39222
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CANNABIDIOL NON-STERILE DRUG SUBSTA...
    Issue/Submission Date
    2023-11-28
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    ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE

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    USDMF

    Found USDMF

    39223
    Active
    ABALOPARATIDE, NON-STERILE BULK DRU...
    2023-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39223
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABALOPARATIDE, NON-STERILE BULK DRU...
    Issue/Submission Date
    2023-11-30
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    Bivalirudin

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    USDMF

    Caution USDMF

    25165
    Inactive
    BIVALIRUDIN, NON-STERILE BULK DRUG ...
    2011-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25165
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BIVALIRUDIN, NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2011-04-14
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    Abaloparatide Acetate

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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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    Atosiban

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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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    Calcitonin

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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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    Carbetocin Acetate

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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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    Degarelix Acetate

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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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    Exenatide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Glatiramer

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
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    Glucagon

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
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    Plecanatide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Somatostatin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Thymalfasin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    Status
     
    Filing Details
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    Thyrotropin-Releasing Hormone

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Status
     
    Filing Details
    Issue/Submission Date
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