Amaran Biotech receives PIC/s GMP certification
Amaran Biotechnology, Inc. has been awarded cGMP certification from the Taiwan Food and Drug Administration (TFDA). The certificate demonstrates that Amaran Biotechnology manufactures and maintains a level of compliance in accordance with the Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/s) Guide to Good Manufacturing Practice (GMP). Its scope covers the manufacture of active pharmaceutical ingredients (API) at Amaran’s manufacturing facility, which is located in Hsinchu Biomedical Science Park.
General Manager Dr. Tessie Che said “This important accomplishment has a direct and positive impact on our business operations as Amaran can now manufacture drugs for the global market. We plan to continue to seek regulatory approval from major Western countries like USA and European countries in order to expand our commercial reach.”