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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Delta Synthetic Co. Ltd

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    Delta Synthetic Co. Ltd

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    01 Chlorhexidine Gluconate (1)

    02 Guaifenesin (1)

    03 Ivermectin (1)

    04 Lidocaine (1)

    05 Lidocaine Hydrochloride (1)

    06 Methocarbamol (1)

    07 Blank (1)

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    01 Active (4)

    02 Inactive (3)

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    01 Valid (3)

    02 Blank (4)

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    01 218MF10093 (1)

    02 218MF10772 (1)

    03 Blank (5)

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    01 Blank (7)

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    Guaifenesin

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    USDMF

    Found USDMF

    5809
    Active
    GUAIFENESIN
    1985-04-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-351 - Rev 02
    Valid
    Guaifenesin, Regular, milled
    2020-06-18
    Japanese DMF

    Found JDMF

    218MF10772
    Japanese Pharmacopoeia guaifenesin ...
    2006-09-22
    Written Confirmation

    Close WC

    Application Number
    5809
    R1-CEP 2009-351 - Rev 02
    218MF10772
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GUAIFENESIN
    Guaifenesin, Regular, milled
    Japanese Pharmacopoeia guaifenesin ...
    Issue/Submission Date
    1985-04-11
    2020-06-18
    2006-09-22
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    Lidocaine

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    USDMF

    Found USDMF

    11339
    Active
    LIDOCAINE
    1995-02-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-320 - Rev 01
    Valid
    Lidocaine
    2020-07-03
    Japanese DMF

    Found JDMF

    218MF10093
    Day stations lidocaine (production ...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    11339
    R1-CEP 2010-320 - Rev 01
    218MF10093
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LIDOCAINE
    Lidocaine
    Day stations lidocaine (production ...
    Issue/Submission Date
    1995-02-10
    2020-07-03
    2006-01-27
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    Lidocaine Hydrochloride

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    USDMF

    Found USDMF

    11338
    Active
    LIDOCAINE HYDROCHLORIDE
    1995-02-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-198 - Rev 00
    Valid
    Lidocaine hydrochloride monohydrate
    2019-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11338
    R1-CEP 2013-198 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LIDOCAINE HYDROCHLORIDE
    Lidocaine hydrochloride monohydrate
    Issue/Submission Date
    1995-02-10
    2019-11-18
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    Methocarbamol

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    USDMF

    Found USDMF

    38631
    Active
    METHOCARBAMOL
    2023-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    38631
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHOCARBAMOL
    Issue/Submission Date
    2023-12-21
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    Chlorhexidine Gluconate

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    USDMF

    Caution USDMF

    5930
    Inactive
    CHLORHEXIDINE GLUCONATE (BULK)
    1985-05-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5930
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE GLUCONATE (BULK)
    Issue/Submission Date
    1985-05-22
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    Ivermectin

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    USDMF

    Caution USDMF

    17673
    Inactive
    IVERMECTIN
    2004-07-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17673
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IVERMECTIN
    Issue/Submission Date
    2004-07-18
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    5771
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1985-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5771
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1985-04-01
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