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List of Drug Master Files (DMF) of Tofacitinib 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 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 33332 TOFACITINIB CITRATE 2018-12-21 Active II N/A
26/09/2024 Metrochem API Private Limited
India
METROCHEM API PRIVATE LTD 35976 TOFACITINIB CITRATE 2021-05-29 Active II N/A