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

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    01 Chlorphenesin (1)

    02 Chlorphenesin Carbamate (1)

    03 Drotaverine (1)

    04 Guaifenesin (2)

    05 Mebeverine (2)

    06 Mephenesin (1)

    07 Methocarbamol (3)

    08 Prazosin Hydrochloride (1)

    09 Sulfogaiacol (1)

    10 Terazosin HCl (1)

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    01 Active (2)

    02 Blank (12)

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    01 Valid (3)

    02 Blank (11)

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    01 Blank (14)

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    01 WC-0020n (2)

    02 WC-0358 (6)

    03 WC-0358A3 (2)

    04 Blank (4)

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    Guaifenesin

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    USDMF

    Found USDMF

    10413
    Active
    GUAIFENESIN USP
    1993-08-13
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-088 - Rev 05
    Valid
    Guaifenesin
    2018-06-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0020n
    Valid
    Guaifenesin USP/Ph. Eur
    2022-07-07
    Application Number
    10413
    R1-CEP 1999-088 - Rev 05
    Indian CDSCO WC-0020n
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    GUAIFENESIN USP
    Guaifenesin
    Guaifenesin USP/Ph. Eur
    Issue/Submission Date
    1993-08-13
    2018-06-26
    2022-07-07
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    Guaifenesin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-065 - Rev 00
    Valid
    Guaifenesin, Unit-II
    2019-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    Gualfenesin (BP/Ph.Eur),
    2022-06-29
    Application Number
    R0-CEP 2019-065 - Rev 00
    Indian CDSCO WC-0358
    Status
    Valid
     
    Valid
    2025-07-14
    Filing Details
    Guaifenesin, Unit-II
    Gualfenesin (BP/Ph.Eur),
    Issue/Submission Date
    2019-11-27
    2022-06-29
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    Mebeverine

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2021-271 - Rev 00
    Valid
    Mebeverine hydrochloride
    2023-09-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    Mebeverine Hydrochloride (BP)
    2022-06-29
    Application Number
    CEP 2021-271 - Rev 00
    Indian CDSCO WC-0358
    Status
    Valid
     
    Valid
    2025-07-14
    Filing Details
    Mebeverine hydrochloride
    Mebeverine Hydrochloride (BP)
    Issue/Submission Date
    2023-09-25
    2022-06-29
    Synthokem Labs

    CPhI Worldwide, Milan

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    Methocarbamol

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    USDMF

    Found USDMF

    10410
    Active
    METHOCARBAMOL USP
    1993-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0020n
    Valid
    Methocarbamol USP
    2022-07-07
    Application Number
    10410
    Indian CDSCO WC-0020n
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-21
    Filing Details
    METHOCARBAMOL USP
    Methocarbamol USP
    Issue/Submission Date
    1993-08-13
    2022-07-07
    Synthokem Labs

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    • FDA
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    Chlorphenesin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    Chlorphensesin (BP)
    2022-06-29
    Application Number
    Indian CDSCO WC-0358
    Status
     
    Valid
    2025-07-14
    Filing Details
    Chlorphensesin (BP)
    Issue/Submission Date
    2022-06-29
    Synthokem Labs

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    Mephenesin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    Mephenesin (BPC)
    2022-06-29
    Application Number
    Indian CDSCO WC-0358
    Status
     
    Valid
    2025-07-14
    Filing Details
    Mephenesin (BPC)
    Issue/Submission Date
    2022-06-29
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    Methocarbamol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    Methocarbamol IH/USP
    2022-06-29
    Application Number
    Indian CDSCO WC-0358
    Status
     
    Valid
    2025-07-14
    Filing Details
    Methocarbamol IH/USP
    Issue/Submission Date
    2022-06-29
    Synthokem Labs

    CPhI Worldwide, Milan

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    Sulfogaiacol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0358
    Valid
    potassium guaiacol sulphonate
    2022-06-29
    Application Number
    Indian CDSCO WC-0358
    Status
     
    Valid
    2025-07-14
    Filing Details
    potassium guaiacol sulphonate
    Issue/Submission Date
    2022-06-29
    Synthokem Labs

    CPhI Worldwide, Milan

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    Mebeverine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0358A3
    Expired
    Mebeverine HCl EP
    2021-04-15
    Application Number
    Indian CDSCO WC-0358A3
    Status
     
    Expired
    2022-07-14
    Filing Details
    Mebeverine HCl EP
    Issue/Submission Date
    2021-04-15
    Synthokem Labs

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    Methocarbamol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0358A3
    Expired
    Methocarbamol USP
    2021-04-15
    Application Number
    Indian CDSCO WC-0358A3
    Status
     
    Expired
    2022-07-14
    Filing Details
    Methocarbamol USP
    Issue/Submission Date
    2021-04-15
    Synthokem Labs

    CPhI Worldwide, Milan

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