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 a 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.
About Bora Pharmaceuticals:
Bora Pharmaceuticals is a premier 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. Bora owns and operates three state-of-the-art CGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. Our TAA-compliant sites deliver to more than 100 markets around the world including the USA, Canada, EU, Southeast Asia, Middle East, and South and Central Americas. Bora handles high potency compounds, solvents, flammables, and IR/SR/ER release profile products.
About KYOWA Pharmaceutical Industry Co. Ltd.:
KYOWA Pharmaceutical Industry Co. Ltd. was established in 1954 and is a premier generic pharmaceutical company. Its most well-known generic drug in Japan is known as “AMEL.” The company’s primary focus is on the Central Nervous System (CNS) related market. KYOWA will help patients and their families as a CNS Total Solution Company that provides comprehensive support throughout their entire lifetime, from disease prevention and promotion of healthy, long life to therapy and prognosis. There are more than 300 products in KYOWA’s portfolio and roughly 60% of the medications are CNS related.
