KYOWA Pharmaceutical Industry Co. Ltd. Partners with Bora Pharmaceuticals to Manufacture Generic Product for Filing in Japan
PR91045
TAIPEI, Aug. 5, 2021 /PRNewswire=KYODO JBN/ --
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 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. For more information visit:
www.boracorpcdmo.com
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. For more information visit:
https://www.kyowayakuhin.co.jp/
SOURCE Bora Pharmaceuticals
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