Jubilant Life gets US FDA approval for Canada Plant
Jubilant Life Sciences has 10 manufacturing facilities in India, US and Canada and is involved in manufacturing active pharmaceutical ingredients (APIs), generics, specialty pharmaceuticals and life science ingredients. It also provides services in contract manufacturing and drug discovery and development.
Recently, the US Food and Drugs Administration (FDA) approved Jubilant’s manufacturing plant in Montreal, Canada, classifying its pharmaceutical manufacturing facility as 'Acceptable'. The plant had received a warning letter in February 2013 for violation of good manufacturing practices. 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 successfully resolves all issues raised by the FDA on the Montreal facility in February 2013.
The company had received two more warning letters from the FDA in December 2013 for its plants in Spokane, US, and Quebec, Canada for non-compliance with good manufacturing practices.