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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Ajanta Pharma Limited to the U.S. FDA. Original Data : FDA Website

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    01 CEFADROXIL USP (1)

    02 DULOXETINE HYDROCHLORIDE USP (1)

    03 MANUFACTURED SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAHARASHTRA, INDIA (1)

    04 RANOLAZINE (1)

    05 VALGANCICLOVIR HYDROCHLORIDE USP (Crystalline) (1)

    06 VORICONAZOLE USP (1)

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    01 AJANTA PHARMA LTD (6)

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    01 India (6)

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    CEFADROXIL USP

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    AJANTA PHARMA LTD
    Inactive
    14201
    N/A
    1999-06-14
    II
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    DULOXETINE HYDROCHLORIDE USP

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    AJANTA PHARMA LTD
    Active
    37458
    Complete
    2022-10-18
    2022-09-29
    2022-09-30
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    RANOLAZINE

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    AJANTA PHARMA LTD
    Active
    37993
    Complete
    2023-07-12
    2023-06-21
    2023-02-06
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    VALGANCICLOVIR HYDROCHLORIDE USP (C...

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    AJANTA PHARMA LTD
    Active
    36194
    Complete
    2021-12-03
    2021-10-13
    2021-10-22
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    VORICONAZOLE USP

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    AJANTA PHARMA LTD
    Active
    38332
    Complete
    2023-10-23
    2023-09-13
    2023-05-30
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    MANUFACTURED SITE, FACILITIES, PERS...

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    AJANTA PHARMA LTD
    Inactive
    12402
    N/A
    1997-03-05
    II
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