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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
12/01/2026 Apex Healthcare Limited
India
APEX HEALTHCARE LTD 42067 ACYCLOVIR USP 2025-07-23 Active II N/A
30/12/2025 Ajinomoto OmniChem N.V.
Belgium
OMNICHEM SA 10124 ACYCLOVIR 1993-03-02 Inactive II N/A