BioDuro recently announced it has established a joint venture with Cenra API Solutions, also as known as Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB), a leading pharmaceutical chemical manufacturer in Taiwan since 1964, 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.”

BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.

Founded in 1964, Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB) operates as Cenra API Solutions, part of the CENRA Group. Cenra was the first API manufacturer in Taiwan to receive U.S. FDA approval and focuses on the development and manufacture of high-value and complex APIs, leveraging advanced biotechnology, fermentation, and chemical synthesis platforms to serve customers in over 50 countries worldwide.