Amaran Biotech Key Milestones
- PIC/S GMP 2021 certificate granted by TFDA in November.
- PIC/S GMP 2019 certificate granted by TFDA in May. Recertification occurs every 2-3 years.
- PIC/S GMP certification granted in June.
- Established and optimized critical processing parameters in the manufacture of 1st & 2nd cGMP products.
- Amaran Biotech delivers the 2nd cGMP product in June.
- Amaran Biotech moves into new facility in March.
- Amaran Biotech receives pharmacist manufacturing license on July 17.
- First successful cGMP production completed on October 5.
- Building A construction completed & Amaran Biotech obtains the occupation permit in October.
- Dr. Tessie Che appointed as Chairman (February) & General Manager (November).
- Groundbreaking ceremony at Hsinchu Biomedical Science Park on July 29.
- Beam-raising ceremony held at Hsinchu Biomedical Science Park on December 2.
- Collaboration agreement with Stellar Biotechnologies, Inc.(USA) signed on December 12, to develop cGMP grade Keyhole Limpet Hemocyanin as sustainable source for the long-term manufacture of OBI-822.
- Amaran Biotechnology Inc. is founded by Chairman Dr. Michael Chang and Huei Hong Investment Co., Ltd. on April 28.