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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 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 33551 SITAGLIPTIN PHOSPHATE USP (ANHYDROUS) 2019-01-31 Active II Complete 2019-09-23 2019-09-13
28/03/2025 Wavelength Pharmaceuticals
Israel
WAVELENGTH ENTERPRISES LTD 39377 SITAGLIPTIN PHOSPHATE MONOHYDRATE 2024-02-02 Active II Complete 2024-05-28 2024-01-22