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List of Drug Master Files (DMF) of Pemetrexed Dipotassium 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 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 31571 PEMETREXED DIPOTASSIUM HEPTAHYDRATE 2017-03-31 Active II N/A
26/09/2024 Shilpa Medicare
India
SHILPA PHARMA LIFESCIENCES LTD 29652 PEMETREXED DIPOTASSIUM (NONA HYDRATE) (PMN) 2015-09-14 Active II Complete 2015-12-15 2015-09-23