Company Profile of Polaris Pharmaceuticals Inc

Polaris is a multi-national Biopharmaceutical Manufacturing Company with R&D Centers in California and Taiwan, with cGMP complied facilities in Vacaville CA, USA and Chengdu, China.Polaris Pharmaceuticals Inc. is a multinational corporation comprising three manufacturing facilities. The California facility specializes in the research and production of E.coli-derived products and holds cGMP certification. The Chengdu facility, known as DesigneRx Pharmaceuticals, features well-established prokaryotic expression systems and advanced eukaryotic expression systems, aiming to become a leading large-scale cGMP production facility. The Taiwan facility, also known as Genovior Biotech, provides technical development and manufacturing services based on PIC/S GMP standards for clients worldwide.

We offer comprehensive CDMO (Contract Development and Manufacturing Organization) services. Our dedicated team is committed to assisting clients throughout the entire project, from early development to commercialization, and providing comprehensive support for IND/NDA/BLA filings. We have a proven track record of successfully manufacturing clinical and commercial products to clients in the United States, Europe, Australia, South Korea, and the Greater China region. By leveraging the resources within the Polaris Group, we offer comprehensive development and manufacturing services to our clients. We specialize in seed bank construction, process development and optimization, analytical method development and optimization, as well as production services in both Non-GMP and GMP stages.

With our small-scale, pilot-scale, and large-scale production platforms, we offer flexible, cost-effective, and efficient solutions tailored to our clients' needs. Our operations are backed by a robust and stable GMP quality management system, ensuring stringent quality controls and compliance with product release standards that meet the regulatory requirements of NMPA/FDA/EMA. Through the integration of research and production resources on both domestic and international fronts, and with the guidance of the Polaris Scientific Advisory Committee, we assist global clients in project localization and international expansion endeavors.