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 manufacturing facility in September 2019. On February 3rd, 2020, EirGenix received PMDA’s official approval in its issued ‘GMP Compliance Inspection Result Notification’, stating EirGenix’s compliance with relevant Japanese regulations regarding the quality, effectiveness and safety of pharmaceutical manufacturing.

The approval is a milestone for EirGenix, as its facility becomes the first GMP biopharmaceutical manufacturing facility in Taiwan to receive the authority’s approval. Now with the PMDA’s authorization for EirGenix to manufacture marketed drug substances in Japan, EirGenix further expands its offerings from early-stage research and development up to commercial manufacturing of marketed products.