BioDuro expands API production to Taiwan through new joint venture with Cenra

TAIWAN—California-based CRDMO BioDuro is strengthening its Asian production capabilities through a new partnership in Taiwan, adding to its existing manufacturing network in mainland China.

The company has formed a joint venture with Cenra API Solutions, a long-established pharmaceutical ingredient manufacturer based in Taiwan.

Through this collaboration, BioDuro gains access to Cenra’s commercial-scale facility located in Taipei, which will integrate into the CRDMO’s existing production operations across multiple sites in China.

Combining expertise and infrastructure

BioDuro brings its early-stage development capabilities to the partnership, while Cenra contributes its extensive manufacturing infrastructure.

The venture aims to deliver comprehensive active pharmaceutical ingredient (API) services, covering everything from initial development stages through full-scale commercial production.

Cenra’s Taipei campus houses 10 API production lines with a combined reactor capacity exceeding 350,000 liters.

BioDuro reports that this facility can produce 200 metric tons of drug ingredients annually, significantly expanding the company’s manufacturing capacity in the region.

BioDuro’s CEO, Armin Spura, Ph.D., explained that merging BioDuro’s integrated chemistry, manufacturing, and controls expertise with Cenra’s nearly 60 years of good manufacturing practice excellence creates stronger global supply chain resilience.

The partnership also reduces technology transfer risks by establishing complementary production capabilities across different geographic locations.

Cenra’s strong regulatory track record

Cenra API Solutions operates as part of Taiwan’s Chunghwa Chemical Synthesis & Biotech Company, which established operations in 1964.

The manufacturer achieved a notable milestone as Taiwan’s first API producer to receive U.S. Food and Drug Administration approval.

Today, Cenra serves clients in more than 50 countries worldwide, demonstrating its international reach and regulatory compliance capabilities.

Strategic manufacturing shifts

BioDuro has actively reconfigured its manufacturing footprint over the past year.

In early 2024, the company opened a new peptide synthesis manufacturing facility at its Shanghai campus, strengthening its presence in mainland China.

The CRDMO took shape in 2015 when early-stage contract research organization BioDuro merged with contract manufacturer Formex, expanding production capacity in the United States while maintaining research operations in China.

More recently, BioDuro completed the sale of its Irvine drug product manufacturing facility to Forma Life Sciences in January.

The company emphasized that this transaction does not alter its identity as a U.S.-headquartered organization, noting that its dedicated drug product team continues operations in China.

CEO Spura characterized the Irvine divestiture as a strategic decision allowing BioDuro to concentrate on its primary strengths in drug discovery, drug substance development, and manufacturing operations moving forward.