BioDuro, a Contract Research, Development, and Manufacturing Organization (CRDMO), has established a joint venture with Cenra API Solutions, a pharmaceutical chemical manufacturer in Taiwan, to add significant commercial-scale active pharmaceutical ingredient (API) manufacturing capacity at Cenra’s campus in Taipei, Taiwan, to BioDuro’s global network.

The joint venture will see BioDuro’s strengths in early-stage drug development integrated with Cenra’s expertise in commercial scale GMP API manufacturing, providing global clients with an end-to-end API solution from early development through to commercial-scale manufacturing.

The Taipei campus houses 10 GMP API production lines with a total reactor volume of more than 350,000 liters to support annual API output of up to 200 metric tons. The facility has been successfully inspected by several major international regulatory agencies, including the U.S. FDA, EMA, Japan’s PMDA, and Taiwan’s 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,” said Armin Spura, Ph.D., CEO of BioDuro. “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, both inside and outside mainland China, accelerating the advance of innovative therapies to market, for patients worldwide.”

“BioDuro serves more than 1,500 global customers annually with industry-leading R&D and manufacturing capabilities,” added Wayne Hsiao, President of Cenra API Solutions. “We are excited to join forces to deliver highly integrated solutions and greater value to customers around the world.”