Jubilant Life Sciences,
an integrated global pharmaceuticals and life sciences company, has announced that the USFDA conducted inspection at a manufacturing facility in Roorkee, India, for solid dosage formulations during August 2018 and was subsequently intimated by the agency of the facility being classified the facility as “Official Action Indicated” (OAI) in December 2018 as well as issued a warning letter for the facility.
The USFDA may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency. However, the company believes that the existing manufacturing and sale of products from this facility will not be impacted.
US revenues from the facility are ~4% of the total revenues of the company.
The company is committed to implementing the necessary corrective actions required to address USFDA concerns and is in the process of providing a thorough and comprehensive response to the USFDA within 15 working days.
Jubilant Life Sciences Ltd is currently trading at Rs756.50 down by Rs27.4 or 3.5% from its previous closing of Rs783.90 on the BSE. The scrip opened at Rs783.50 and has touched a high and low of Rs795.90 and Rs747.30 respectively.