Bora Pharmaceuticals Completes Health Canada Inspection
Bora Pharmaceutical Services Inc., a division of Bora Pharmaceuticals, has announced that its Mississauga, Ontario contract manufacturing and packaging facility has successfully completed its first Health Canada inspection since being aquired by the company.
The two-week inspection confirmed Bora’s cGMP systems are in compliance with Health Canada standards.
The Mississauga, Ontario site is one of Bora’s three state-of-the-art contract manufacturing (CMO) facilities worldwide which collectively supply pharmaceutical products to over 100 markets.
“The successful completion of the Health Canada audit demonstrates that Bora Pharmaceuticals is dedicated to meeting the most stringent regulatory standards in the industry, and delivering the highest quality prodcts to our clients” said Bobby Sheng, CEO, Bora Pharmaceuticals.
The Mississauga, Ontario site has also completed CGMP inspections by the U.S. FDA, the Japanese PMDA, ANVISA, Korean FDA, Turkish Ministry of Health, and the Russian Federation.
Andrew Ehrat, General Manager at the site, added: “The favorable outcome from this inspection reflects Bora’s commitment to continuous improvement in our quality systems and processes to meet the needs of our global clients.”
Bora acquired the Mississauga plant from GSK in late 2020. The site is the company’s first manufacturing facility in North America and is home to its headquarters in the region.
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.