We offer a wide range of dosage form manufacturing and development capabilities, providing high pharmaceutical quality that has been broadly certified.
We own the first U.S. FDA-approved manufacturing facility for injections in Asia (besides Japan).
Our sterile injectable line is PIC/S GMP certified and has passed onsite inspection from Taiwan FDA and Japan PMDA, and even the stringent inspection of the U.S. FDA. Our products are marketed to major markets including the U.S. and Japan. Compared to other dosage forms, the production of injectables is uniquely challenging, but we manage to achieve the technique to maintain sterility of manufacturing process. With our professional personnel, strict in-process control and environmental monitoring, and constant maintenance of instruments and facilities, we guarantee that our injectable products meet the most up-to-date international standard.
Our sterile injectables production line can offer a maximum batch size of 200L for a wide range of filling volumes:
Vial: 1mL – 30mL
Ampoule: 1mL – 20mL
Furthermore, in response to the increasing global demand for injectable products, we are building a new sterile vial production line. This production line will be able to manufacture a maximum batch size of 500L with filling volume ranging from 0.2mL to 100mL vials, under maximum filling speed of 24,000 vials per hour (2mL vial). We anticipate to receive the PIC/S GMP certification for this new line and start its commercial operations in Q2 2023.