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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 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 37854 PONATINIB HYDROCHLORIDE 2022-12-31 Active II N/A
28/03/2025 Signa S.A. de C.V.
Mexico
ZHEJIANG LEPU PHARMACEUTICAL CO LTD 35413 PONATINIB HYDROCHLORIDE 2020-12-16 Active II Complete 2021-01-29 2020-11-27