Jubilant Life Sciences announces successful resolution to FDA Warning Letter for Montreal Facility

Jubilant Life Sciences announces successful resolution to FDA Warning Letter for Montreal Facility

28 Feb 14

Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company announced today that it has received a communication from the U.S. Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as 'Acceptable'. This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications.

The development follows completion of FDA's review of the Company's responses post the February letter and the subsequent re-inspection conducted at Jubilant's Montreal facility in September, 2013. This development successfully resolves the FDA issues at our Montreal facility.

About Jubilant Life Sciences

Jubilant Life Sciences Limited is a global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Generics, Specialty Pharmaceuticals and Life Science Ingredients. It also provides Services in Contract Manufacturing and Drug Discovery and Development. The Company's strength lies in its unique offerings of Pharmaceutical and Life Sciences products and services across the value chain. With 10 world-class manufacturing facilities in India, US and Canada and a team of over 6,300 multicultural people across the globe, the Company is committed to deliver value to its customers spread across 100 countries. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals and life sciences companies globally.
For more info: www.jubl.com.

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.