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Eirgenix Receives PMDA Approval

Biopharmaceutical manufacturing facility becomes the first in Taiwan to receive Japan's GMP approval

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By: Kristin Brooks

Managing Editor, Contract Pharma

EirGenix, Inc., a provider of CDMO services, has undertaken the transfer of drug substance manufacturing of a marketed drug from a Japanese pharmaceutical company and has since fulfilled all the regulatory requirements necessary to complete the manufacturing site transfer. The independently administered Pharmaceutical and Medical Devices Agency (PMDA), under Japan’s Ministry of Health, Labour, and Welfare, carried out its on-site inspection of EirGenix’s biopharmaceutical manufact...

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