- BioDuro has established a joint venture with Cenra API Solutions to expand commercial-scale API manufacturing capacity at Cenra’s Taipei campus in Taiwan.
- The collaboration integrates BioDuro’s early-stage drug development capabilities with Cenra’s GMP API manufacturing expertise to provide end-to-end drug substance services.
BioDuro has announced the formation of a joint venture with Cenra API Solutions, also known as Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB), to expand commercial-scale active pharmaceutical ingredient (API) manufacturing capacity at Cenra’s campus in Taipei, Taiwan. The partnership will add new production capabilities to BioDuro’s global Contract Research, Development, and Manufacturing Organization (CRDMO) network.
The joint venture integrates BioDuro’s early-stage drug development capabilities with Cenra’s expertise in GMP API manufacturing. According to the companies, the collaboration is designed to provide pharmaceutical and biotechnology customers with an end-to-end API solution covering development through commercial-scale production.
Cenra’s Taipei facility includes 10 GMP API production lines with a total reactor capacity exceeding 350,000 liters, supporting an annual API output of up to 200 metric tons. The site has undergone inspections by several international regulatory agencies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Taiwan’s Food and Drug Administration (TFDA).
“By combining BioDuro’s integrated CMC expertise with Cenra’s nearly six decades of GMP manufacturing excellence and enviable international regulatory history, our joint venture strengthens both companies’ global supply chain resilience and minimizes the risks of technology-transfers. This collaboration allows us to provide customers with truly integrated services and a drug substance solution that spans discovery chemistry, process R&D, regulatory starting materials, advanced intermediates, and clinical- to commercial-scale API production.”
Armin Spura, Ph.D., CEO of BioDuro
