Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB), now operating as CENRA API Solutions (CAS/CENRA), is a distinguished Taiwanese API manufacturer with nearly six decades of experience, having been founded in 1964. CAS holds the pioneering distinction of being the first registered and largest bulk pharmaceutical chemical manufacturer in Taiwan, and the first plant in Taiwan to be approved by the US FDA, achieved in 1984. The company has established a robust global footprint, with approximately 75% of its business derived from North America and Europe, and its APIs are supported by Drug Master Files (DMFs) filed in over 50 countries worldwide.
CAS’s core competency is defined by its expertise in both chemical synthesis and microbial fermentation technologies, positioning it within a unique niche in the global pharmaceutical industry. The company provides comprehensive CMO/CDMO services, utilizing facilities that include a total of 10 segregated cGMP production lines: 8 for chemical synthesis (including 6 commercial lines) and 2 for fermentation. Manufacturing capabilities are highly scalable, with reactor volumes ranging up to 20 tons in synthesis and large-scale fermenters reaching 30,000 L.
The company specializes in high-value APIs, including fermentation-derived immunosuppressants like Rapamycin (Sirolimus), Everolimus, and Tacrolimus. CAS also demonstrates strong R&D capabilities in peptide synthesis, employing both Solid-Phase Peptide Synthesis (SPPS) and Liquid-Phase Peptide Synthesis (LPPS). For complex products like Semaglutide, CAS utilizes an innovative semi-recombinant process that combines biological fermentation and solid-phase peptide synthesis to optimize production for high yield, low cost, and high purity. CAS continuously adheres to rigorous quality and compliance standards, having successfully passed inspections from major global regulatory bodies, including the US FDA, Japan's PMDA, and EU authorities.

CENRA API Solutions/CCSB

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CENRA API Solutions/CCSB

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