Kyowa Pharmaceutical has contracted Bora Pharmaceutical Laboratories, a division of Bora Pharmaceuticals for the manufacturing of a generic product for filing in Japan. Kyowa will be the first Japanese client for Bora’s Zhunan manufacturing site, which is USFDA, MHRA, and TFDA approved.
This project will coordinate is hoped to increase the visibility of Taiwan’s pharmaceutical capabilities, Bora says, while demonstrating cooperation between Japan’s and Taiwan’s pharmaceutical sectors.
Once manufactured, the batches will be used to support bioequivalence (BE) studies and then submitted to Japan’s PMDA for approval. Once approved, Bora will be the commercial manufacturing site for the generic product production.
