Japan’s Kyowa Inks Deal with Taiwan’s CDMO Firm to Manufacture Generic Drugs

Japanese drugmaker Kyowa Pharma and Taiwan’s CDMO firm Bora Pharmaceuticals announced a manufacturing pact on August 5th. As per the terms, Bora will help produce Kyowa’s generic products at its Zhunan site in Taiwan, but the details remain undisclosed.

Kyowa’s Focus on CNS Drugs

Kyowa has been in the industry for over 65 years. The firm is best known for developing generic drugs for treating patients with central nervous system (CNS) diseases, which take up over 59% of the company’s portfolio. Its pipeline includes Neuropsychiatric drugs, antiparkinsonian drugs, ​​anxiolytics, and antiepileptic. Other than CNS drugs, Kyowa also invests in developing cardiovascular medicines.

Support for BE Studies and Commercial Production

Bora said it will deliver batches for bioequivalence (BE) studies and handle the submission to Japan’s PMDA for approval. Bora will be the commercial manufacturing site for the generic product if the drugs get the nod.

The Zhunan plant has gained approval from the USFDA (2009), TFDA (2010), and MHRA (2015). It is a 36,000 plus square meter CMO facility with cGMP compliant manufacturing and packaging services. Other than that, Bora has two other sites, one in Tainan, Taiwan, and the other in Ontario, Canada.

Upon the deal, Kyowa will become Bora’s first Japanese client.

Author

Tyler Chen

"Never go to a doctor whose office plants have died."- Erma Bombeck