Adimmune Corporation (TWSE: 4142) today announced that its second automated aseptic filling and packaging line has successfully completed GMP inspection by the U.S. Food and Drug Administration (FDA). The company has also received formal notification from its international partner, Sanofi, to commence parallel production using both Line 1 and Line 2 starting in June. This expansion will double production capacity from 5 million to 10 million doses, with output from international contract manufacturing projects expected to increase significantly year-over-year.   

Driven by continued growth in Sanofi’s product demand across the U.S. and European markets, the partner requested additional capacity and the introduction of a second production line. In response, both parties initiated a capacity expansion program in 2024 and executed a supply expansion agreement in 2025. Over the past two years, close collaboration enabled completion of facility upgrades, process validation, and regulatory submissions to the FDA. In late March this year, an FDA inspection team conducted an on-site GMP audit at Adimmune’s facility over the course of approximately one week.   

Separately, Adimmune’s trivalent and quadrivalent influenza vaccines have recently obtained HALAL certification issued by the Taiwan Halal Integrity Development Association (THIDA), confirming compliance with Halal requirements across raw materials and manufacturing processes. THIDA is a recognized certification body in ASEAN Muslim markets, including Indonesia and Malaysia. HALAL certification is a key consideration for Muslim consumers and represents further validation of the quality of Adimmune’s domestically produced influenza vaccines, strengthening the company’s position to enter Muslim markets.