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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 31095 COLESEVELAM HYDROCHLORIDE 2016-11-04 Active II Complete 2017-01-30 2016-10-28
28/03/2025 CTX Lifesciences
India
CTX LIFE SCIENCES PVT LTD 27492 COLESEVELAM HYDROCHLORIDE 2013-09-27 Inactive II N/A