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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 Bachem AG
Switzerland
BACHEM SA 9972 5-AMINOLEVULINIC ACID HYDROCHLORIDE 1992-11-25 Active II N/A
28/03/2025 Heraeus Holding
Germany
HERAEUS PRECIOUS METALS GMBH AND CO KG 24359 5-AMINOLEVULINIC ACID HYDROCHLORIDE 2010-11-12 Active II N/A