Jubilant Life Sciences Ltd, an integrated pharmaceuticals and life sciences company, today announced successful resolution of USFDA warning letter for its Montreal facility.
We have received a communication from the US 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, a statement issued here said.
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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, it said.
Jubilant Life Sciences is 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 has 10 manufacturing facilities in India, US and Canada and a team of over 6,300 people across the globe.