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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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 23436 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) 2009-12-31 Active II Complete 2013-10-07 2013-09-26
28/03/2025 Biocare Pharmaceutical
Turkey
CHONGQING BIOCARE PHARMACEUTICAL LTD 23974 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG 2010-07-06 Active II Complete 2014-03-10 2013-09-16