Noida: Jubilant Life Sciences said on Friday that the US Food and Drug Administration (USFDA) has issued a warning letter after conducting an inspection at its manufacturing facility in Roorkee, Uttarakhand.
The inspection for solid dosage formulations was conducted during August 2018. The integrated global pharmaceuticals and life sciences company was later intimated by the USFDA of the facility being classified as ‘Official Action Indicated’ in December last year. A warning letter was issued as well.
The USFDA may withhold approval of any new applications or supplements till Jubilant addresses all issues. However, the company said that its existing manufacturing and sale of products from this facility will not be impacted.
US revenues from the facility are about 4 per cent of the company’s total revenues.
“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,” the firm informed stock exchanges in regulatory filings.
[source_without_link]ANI[/source_without_link]