Shares of Divi's Laboratories jumped as much as 8 per cent to an intraday high of Rs 1,089.90 against the previous close of Rs 1,009.75 as the company said that the US health regulator has “closed out” a warning letter issued to the company's unit at Visakhapatnam following evaluation of corrective actions taken by it.
“Divi’s Laboratories has been informed by USFDA that the agency has completed evaluation of the company’s corrective actions in response to FDA’s warning letter..dated April 13, 2017,” the drug maker said in a BSE filing today.
“We also note from the update on FDA’s website that they have closed out the warning letter,” it added.
Last week,
USFDA had in March had issued an import alert under clauses 99-32 and 66-40, and a warning letter later for the Visakhapatnam facility for non-compliance of good manufacturing practice (GMP) norms, the company had informed the bourses earlier.
The company had in July announced that USFDA had moved to lift import alert 99-32 imposed on the unit.
As per USFDA, an import alert under 66-40 entails “detention without physical examination” of drugs from firms which have not met drug GMPs, while alert under 99-32 is issued to “firms refusing FDA foreign establishment inspection”.