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List of Drug Master Files (DMF) of Pyrantel 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 Megafine Pharma (P) Limited
India
MEGAFINE PHARMA P LTD 20613 PYRANTEL PAMOATE USP (NON STERILE DRUG SUBSTANCE) 2007-06-15 Active II N/A
26/09/2024 COSMA S.p.A
Italy
COSMA SPA 7669 PYRANTEL PAMOATE 1988-09-09 Active II N/A