Bora Pharmaceuticals and KYOWA agree generic manufacturing contract
Bora Pharmaceuticals' Zhunan facility
KYOWA Pharmaceutical Industry will be the CDMO's first Japanese client for its Zhunan manufacturing site
Bora Pharmaceutical Laboratories, a division of Bora Pharmaceuticals, has agreed to manufacture KYOWA Pharmaceutical Industry's generic drug product for filing in Japan.
The CDMO, which specialises 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, will manufacture the product from its Zhunan, Taiwan, site.
The manufactured batches will be used to further support bioequivalence studies and then submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval.
Once approved has been gained, Bora will start commercial production of generic product from the same site, which it acquired in 2018.
KYOWA will be the first Japanese client for Bora’s Zhunan manufacturing site, which has been approved by the US FDA, MHRA, and TFDA.
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