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List of Drug Master Files (DMF) of Insulin Bovine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Fujifilm Diosynth Biotechnologies
United Kingdom
DIOSYNTH BV 14382 BOVINE INSULIN HIGHLY PURIFIED 1999-09-02 Inactive II N/A
26/09/2024 Fujifilm Diosynth Biotechnologies
United Kingdom
DIOSYNTH BV 3881 BOVINE INSULINE HIGHLY PURIFIED 1980-06-30 Inactive II N/A