Manufacturing

State-of-the-art biologics production facilities

PharmaEssentia USA works with the global PharmaEssentia organization, third party manufacturing companies and regulatory authorities to fulfill its commitment to an uninterrupted supply of medical products for patients who need them. Within the US and our global affiliates, PharmaEssentia has strong manufacturing and quality expertise and we seek to continually improve and expand our supply chain within the US and globally.

GMP production plant

Our main manufacturing facility at Central Taiwan Science Park in Taichung City includes a PEG production plant, a biologic drug substance production plant, and an aseptic filling plant. Two Drug Substance (DS) production lines provide capacity to support up to 40,000 patients.

Expanding our capacity

Our new facilities, expected to be completed by 2026, will expand our production capacity to serve more than 100,000 patients worldwide. In addition, efforts are underway to expand components of our manufacturing efforts in the United States, including fill and finish.

Quality management

PharmaEssentia is committed to ensuring the highest standards of product quality and patient safety. Our robust Quality Management System meets Good Manufacturing Practice (GMP) requirements. We are regularly inspected by the relevant authorities, including the US FDA, EMA, Taiwan FDA, and the PMDA.

“Quality is at the heart of everything we do. From creating clear SOPs to ensuring compliance with global standards, our goal is to make sure every product we deliver is safe, effective, and consistent—because patients rely on us.”

Janice Hao
Senior Manager, Quality Assurance

Learn More About Our Pipeline And Innovation