Member Profile

Formosa Laboratories Inc. was founded in Taiwan since 1995, and started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspections from regulatory authorities around the world, we also provide CDMO service extending from APIs and ADCs (Antibody Drug Conjugates) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Formosa Laboratories is able to offer full-service GMP manufacturing for drug substance, ADCs and drug product with its API and injectable facilities that accommodates small molecules, biologics and ADCs from pilot scale to commercial scale, all under regulated or cytotoxic control and GMP compliance.

Company Milestones

   2013 Passed joint GMP inspection by EDQM and BGC Hamburg
   2010 Passed 1st PAI for Mycophenolate Mofetil by COFEPRIS of Mexico
   2009 Passed 1st PAI for Gadodiamide by PMDA of Japan
   2007 Passed 1st GMP inspection by BSG of Hamburg, Germany
   2004 Passed 1st PAI by US FDA for Leflunomide API