Taiwan-based EirGenix Inc (6589, TT) has undertaken the transfer of drug substance manufacturing of a marketed drug from a Japanese pharmaceutical company and has completed all the regulatory requirements required to complete the manufacturing site transfer, it was reported on Friday.

The independently administered Pharmaceutical and Medical Devices Agency (PMDA), under Japan's Ministry of Health, Labour and Welfare, conducted its on-site inspection of the company's biopharmaceutical manufacturing facility from 9 September to 12 September 2019. An inspection and approval from the PMDA authorises the company to sell back the manufactured drug substance to its Japanese customer to ultimately be sold on the Japanese market.

EirGenix reportedly received PMDA approval in its issued 'GMP Compliance Inspection Result Notification', regarding its compliance with relevant Japanese regulations regarding the quality, effectiveness and safety of pharmaceutical manufacturing on 3 February 2020.