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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
28/10/2024 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 34400 SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE) 2019-12-30 Active II Complete 2020-12-18 2020-09-16
28/10/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 36129 SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE 2021-07-19 Active II N/A