Divis Labs soars 8 percent as USFDA closes out warning letter on Vizag unit
New Delhi: Shares of Divis Laboratories jumped as much as 8 percent 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.
“Divis Laboratories has been informed by USFDA that the agency has completed the 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.
“We also note from the update on FDA’s website that they have closed out the warning letter,” it added.
Last week, Divi’s Laboratories had informed that the US health regulator would lift an import alert imposed on the company’s Unit-II in Visakhapatnam and was moving to close out the warning letter issued to the unit.
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.