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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
29/11/2025 Enaltec Labs
India
ENALTEC LABS PRIVATE LTD 31387 NEOSTIGMINE METHYLSULFATE USP 2018-03-05 Active II Complete 2018-04-27 2018-03-15
29/11/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 33130 NEOSTIGMINE METHYLSULFATE USP 2018-08-30 Active II Complete 2018-10-11 2018-08-29