Libra Medicine's partner company, Mycenax Biotech Inc., has received conformity approval from the European Medicines Agency (EMA).

Our partner company, Mycenax, conducted an on-site inspection by the EMA (in January 2025) and received formal periodic synthesis approval notification in March 2025.
As a result, we have completed inspections by regulatory authorities in Japan, Canada, and Europe over the last two quarters and received official "pass" notifications.
【Health Canada】
(October 2024) – Conducted a 5-day on-site inspection, completed one day ahead of schedule. Received formal "pass" notification in December 2024.
【PMDA】
(November 2024) – Conducted a 4-day on-site inspection, completed half a day ahead of schedule. Received formal "pass" notification in February 2025.
【EMA】
(January 2025) – Conducted a 10-day on-site inspection, completed two days ahead of schedule. Received formal "pass" notification in March 2025.
The fact that these inspections were completed earlier than initially planned indicates that Mycenax's manufacturing facilities and quality management systems are highly regarded by international regulatory authorities.

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