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List of Drug Master Files (DMF) of Catalase 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 Hubei Gedian Humanwell Pharmaceutical
China
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO LTD 34433 ETHYLPARABEN 2020-01-07 Active IV N/A
26/09/2024 Roche Diagnostics GmbH
Germany
BOEHRINGER MANNHEIM GMBH 8106 CATALASE THERAPEUTIC GRADE 1989-06-12 Inactive II N/A