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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhejiang Langhua Pharmaceutical Co., Ltd.

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    ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD.

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    01 Bupropion Hydrochloride (1)

    02 Ciprofloxacin Hydrochloride (2)

    03 Empagliflozin (1)

    04 Enrofloxacin (1)

    05 Ethyl Loflazepate (1)

    06 Levofloxacin (1)

    07 Levofloxacin Hemihydrate (1)

    08 Spironolactone (1)

    09 Sulbactam (1)

    10 Zidovudine (1)

    11 Blank (1)

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    01 Active (5)

    02 Inactive (2)

    03 Blank (5)

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    01 Valid (4)

    02 Blank (8)

    filter

    01 219MF10194 (1)

    02 219MF10313 (1)

    03 223MF10021 (1)

    04 230MF10143 (1)

    05 231MF10058 (1)

    06 302MF10056 (1)

    07 Blank (6)

    filter

    01 Blank (12)

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    Spironolactone

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    USDMF

    Found USDMF

    26881
    Active
    SPIRONOLACTONE
    2013-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-203 - Rev 01
    Valid
    Spironolactone
    2013-05-14
    Japanese DMF

    Found JDMF

    231MF10058
    Spironolactone at Zhejiang provinci...
    2019-02-25
    Written Confirmation

    Close WC

    Application Number
    26881
    R1-CEP 2004-203 - Rev 01
    231MF10058
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SPIRONOLACTONE
    Spironolactone
    Spironolactone at Zhejiang provinci...
    Issue/Submission Date
    2013-02-04
    2013-05-14
    2019-02-25
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    Levofloxacin Hemihydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2019-111 - Rev 02
    Valid
    Levofloxacin hemihydrate
    2023-11-29
    Japanese DMF

    Found JDMF

    230MF10143
    Levofloxacin hydrate at Zhejiang pr...
    2018-10-12
    Written Confirmation

    Close WC

    Application Number
    CEP 2019-111 - Rev 02
    230MF10143
    Status
    Valid
     
    Filing Details
    Levofloxacin hemihydrate
    Levofloxacin hydrate at Zhejiang pr...
    Issue/Submission Date
    2023-11-29
    2018-10-12
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    Zidovudine

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    USDMF

    Found USDMF

    26695
    Active
    ZIDOVUDINE (NON-STERILE, BULK FORM)
    2012-10-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-341 - Rev 00
    Valid
    Zidovudine
    2021-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26695
    R1-CEP 2012-341 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ZIDOVUDINE (NON-STERILE, BULK FORM)
    Zidovudine
    Issue/Submission Date
    2012-10-19
    2021-01-18
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    Ciprofloxacin Hydrochloride

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    USDMF

    Caution USDMF

    19876
    Inactive
    CIPROFLOXACIN HYDROCHLORIDE
    2006-10-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10021
    CIPROFLOXACIN HYDROCHLORIDE at Zhej...
    2011-02-08
    Written Confirmation

    Close WC

    Application Number
    19876
    223MF10021
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE
    CIPROFLOXACIN HYDROCHLORIDE at Zhej...
    Issue/Submission Date
    2006-10-16
    2011-02-08
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    Ciprofloxacin Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10313
    Ciprofloxacin Hydrochloride at Zhej...
    2007-10-05
    Written Confirmation

    Close WC

    Application Number
    219MF10313
    Status
     
    Filing Details
    Ciprofloxacin Hydrochloride at Zhej...
    Issue/Submission Date
    2007-10-05
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    Empagliflozin

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    USDMF

    Found USDMF

    36541
    Active
    EMPAGLIFLOZIN (NON-STERILE ACTIVE P...
    2021-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36541
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EMPAGLIFLOZIN (NON-STERILE ACTIVE P...
    Issue/Submission Date
    2021-12-02
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    Enrofloxacin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2012-034 - Rev 02
    Valid
    Enrofloxacin for veterinary use
    2023-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2012-034 - Rev 02
    Status
    Valid
     
    Filing Details
    Enrofloxacin for veterinary use
    Issue/Submission Date
    2023-10-04
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    Ethyl Loflazepate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10056
    Ethyl Loflazepate Intermediate at Z...
    2020-05-12
    Written Confirmation

    Close WC

    Application Number
    302MF10056
    Status
     
    Filing Details
    Ethyl Loflazepate Intermediate at Z...
    Issue/Submission Date
    2020-05-12
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    Levofloxacin

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    USDMF

    Found USDMF

    26712
    Active
    LEVOFLOXACIN
    2012-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26712
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LEVOFLOXACIN
    Issue/Submission Date
    2012-12-06
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    Sulbactam

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10194
    Sulbactam at Zhejiang provincial ch...
    2007-06-08
    Written Confirmation

    Close WC

    Application Number
    219MF10194
    Status
     
    Filing Details
    Sulbactam at Zhejiang provincial ch...
    Issue/Submission Date
    2007-06-08
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