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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
31/10/2025 Mankind Pharma
India
MANKIND PHARMA LTD 33565 AMITRIPTYLINE HYDROCHLORIDE USP 2019-07-24 Active II Complete 2019-09-16 2019-07-15
31/10/2025 ACIC Europe API & Pharmaceuticals
Cyprus
ACIC LTD 4311 PROCEDURES FOR 1981-10-19 Inactive II N/A