KYOWA Pharmaceutical Industry Co. Ltd., a premier Japanese pharmaceutical company, has contracted with Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals for the manufacturing of generic product for filing in Japan. KYOWA will be the first Japanese client for Bora’s Zhunan manufacturing site which is already USFDA, MHRA, and TFDA approved.
This project will coordinate the manufacturing strengths in Taiwan and increase the visibility of Taiwan’s pharmaceutical capabilities. It further demonstrates the cooperation between Japan’s and Taiwan’s pharmaceutical companies.
The manufactured batches will be used to further support Bioequivalence (BE) studies and then submitted to Japan’s PMDA for approval. Upon PMDA’s approval, Bora will be the commercial manufacturing site for the generic product production. Bora Pharmaceuticals’ sites already have an excellent track record with many regulatory agencies around the world including the USFDA, MHRA, TFDA, ANVISA, Health Canada, and many others.