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Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.
On August 5th, 2021, Kyowa Pharmaceutical Industry, a pharmaceutical manufacturer known for making generic-drug product, and Bora Pharmaceuticals, a contract development and manufacturing organization (CDMO), announced that they have entered a partnership to produce generic-drug products in Japan.
This agreement will see Bora produce batches for bioequivalence studies and then submitted to Japan’s Product Development and Management Association (PDMA) for approval. Following approval, Bora’s manufacturing site in Zhunan, Taiwan will become the commercial manufacturing site for Kyowa’s generic-drug production.
Kyowa will be the first Japanese client utilizing Bora’s Zhunan manufacturing site. Bora has previously gained approval with regulatory boards in the United States, United Kingdom, Brazil, Canada, and others.
Sources: Bora Corp