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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 Ipca Laboratories
India
IPCA LABORATORIES LTD 25258 PRIMAQUINE PHOSPHATE USP 2011-10-11 Active II Complete 2013-08-07 2013-07-30
28/03/2025 Viatris
U.S.A
TIANISH LABORATORIES PRIVATE LTD 27260 PRIMAQUINE PHOSPHATE, USP 2013-07-29 Active II Complete 2013-09-16 2013-07-22