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).
Lyophilized injections are manufactured in a sterile environment at low temperatures using a vacuum, which results in sublimation to remove water in pre-frozen drug solution by changing their state directly from solid (ice) to gas (vapor).
Lyophilized drugs have a key advantage: its porous, sponge-like structure provides great rehydration ability while containing very little water. This manufacturing process is able to increase the stability of active ingredients, which makes storage and transportation more flexible.
Our lyophilized injection line is PIC/S GMP certified and has passed inspections from both the Taiwan FDA and U.S. FDA. The current capacity is 20,000 vials per batch (approx.) for 2mL lyophilized injections and 10,000 vials per batch (approx.) for 10mL lyophilized injections.