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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
28/03/2025 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INDIA PVT LTD 27923 ETRAVIRINE 2014-03-07 Inactive II N/A
28/03/2025 Hetero Drugs
India
HETERO LABS LTD 35835 ETRAVIRINE PREMIX 2021-06-15 Active II Complete 2021-07-20 2021-06-17