BioDuro announced that it established a joint venture with Cenra API Solutions, also known as Chunghwa Chemical Synthesis & Biotech Co.
The joint venture aims to combine the services of the CRDMO and a pharmaceutical chemical manufacturer. They hope to add significant commercial-scale active pharmaceutical ingredient (API) manufacturing capacity at Cenra’s campus in Taipei, Taiwan, to BioDuro’s global network.
BioDuro said the venture combines its strengths in early-stage drug development with Cenra’s API manufacturing prowess. It provides clients with an end-to-end API solution from early development through to commercial-scale manufacturing.
Cenra’s Taipei campus houses 10 GMP API production lines. It features 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 major regulatory agencies, including the 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.”
Added Wayne Hsiao, President of Cenra API Solutions: BioDuro serves more than 1,500 global customers annually with industry-leading R&D and manufacturing capabilities. We are excited to join forces to deliver highly integrated solutions and greater value to customers around the world.”
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