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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Saraca Laboratories Limited

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    01 Gabapentin (2)

    02 Ranitidine Hydrochloride (2)

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    01 Active (1)

    02 Inactive (2)

    03 Blank (1)

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    01 Valid (2)

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    01 WC-0185 (2)

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    Gabapentin

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    USDMF

    Found USDMF

    30809
    Active
    GABAPENTIN USP
    2017-07-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-092 - Rev 00
    Valid
    Gabapentin
    2022-04-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0185Amended
    Expired
    Gabapentin BP/EP/USP
    2019-11-06
    Application Number
    30809
    R1-CEP 2016-092 - Rev 00
    Indian CDSCO WC-0185Amended
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    GABAPENTIN USP
    Gabapentin
    Gabapentin BP/EP/USP
    Issue/Submission Date
    2017-07-13
    2022-04-29
    2019-11-06
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    Ranitidine Hydrochloride

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    USDMF

    Caution USDMF

    17698
    Inactive
    RANITIDINE HYDROCHLORIDE (FORM-II)
    2004-09-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-057 - Rev 08
    Valid
    Ranitidine hydrochloride
    2022-10-20
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0185
    Expired
    Ranitidine HCl (Ph. Eur./BP/USP/JP)
    2019-07-22
    Application Number
    17698
    R1-CEP 2004-057 - Rev 08
    Indian CDSCO WC-0185
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    RANITIDINE HYDROCHLORIDE (FORM-II)
    Ranitidine hydrochloride
    Ranitidine HCl (Ph. Eur./BP/USP/JP)
    Issue/Submission Date
    2004-09-22
    2022-10-20
    2019-07-22
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    Gabapentin

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0185
    Expired
    Gabapentine Ph. Eur./BP/USP
    2019-07-22
    Application Number
    Indian CDSCO WC-0185
    Status
     
    Expired
    2022-07-21
    Filing Details
    Gabapentine Ph. Eur./BP/USP
    Issue/Submission Date
    2019-07-22
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    Ranitidine Hydrochloride

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    USDMF

    Caution USDMF

    19973
    Inactive
    RANITIDINE HCI (FORM-I)
    2006-11-08
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    19973
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RANITIDINE HCI (FORM-I)
    Issue/Submission Date
    2006-11-08
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