USFDA lifts import alert on Divi's Lab unit

New Delhi, Nov 15 (PTI) Drug firm Divi's Laboratoriestoday said the US health regulator has lifted import alertimposed on its unit at Visakhapatnam...

New Delhi, Nov 15 (PTI) Drug firm Divi's Laboratoriestoday said the US health regulator has lifted import alertimposed on its unit at Visakhapatnam.

Last week, the company in a regulatory filing had saidthe US Food and Drug Administration (USFDA) had "closed out" awarning letter issued to the unit in Visakhapatnam followingevaluation of corrective actions taken by the company at theplant.

"The FDA's website has now been updated on November 14,2017, and the import alert 66-40 on the company's unit-II hasbeen removed," the company said in a BSE filing.

The USFDA in March had issued import alert under clauses99-32 and 66-40 and a warning letter later for theVisakhapatnam facility for non-compliance of goodmanufacturing practices (GMP) norms, the company had informedbourses earlier.

The company in July announced that the USFDA had moved tolift Import Alert 99-32 imposed on the unit. As per the USFDA,an import alert under 66-40 entails "detention withoutphysical examination" of drugs from firms which have not metdrug GMPs while alert under 99-32 is issued to "firms refusingFDA foreign establishment inspection".

The stock was trading 0.41 per cent higher at Rs 1,028.50in the morning session on the BSE. PTI SVKARD.

This is unedited, unformatted feed from the Press Trust of India wire.

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