KYOWA, Bora Pharmaceuticals Enter Mfg. Pact

KYOWA Pharmaceutical Industry Co. Ltd., a Japanese pharmaceutical company, has contracted with Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals, for the manufacture 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.

The project will leverage manufacturing strengths in Taiwan, China and increase the visibility of Taiwan, China’s pharmaceutical capabilities. It also demonstrates the cooperation between Japan’s and Taiwan, China’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 approval, Bora will be the commercial manufacturing site for the generic product production. Bora’s sites have an excellent track record with many regulatory agencies around the world including the USFDA, MHRA, TFDA, ANVISA, Health Canada, and others.

Bora Pharmaceuticals is an international cGMP CDMO specializing in complex oral solid dosage, non-sterile liquids, Nasal sprays, and semi-solids pharmaceutical Rx and OTC products for late-phase Clinical through Commercial manufacturing and packaging.