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List of Drug Master Files (DMF) of Bucillamine 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 Kyowa Hakko Bio
Japan
KYOWA HAKKO KOGYO CO LTD 12270 BUCILLAMINE BULK SUBSTANCE 1996-11-22 Inactive II N/A
26/09/2024 Optimus Pharma
India
OPTIMUS DRUGS PRIVATE LTD 36652 BUCILLAMINE 2021-12-23 Active II N/A