Mumbai: Hyderabad-based Divis Laboratories said on Thursday that the US Food and Drugs Administration (USFDA) will lift an import alert imposed on its Unit-II in Visakhapatnam. The announcement led to its shares surging almost 17 per cent on the BSE.
In a filing with the stock exchanges, Divis Laboratories said the US drug regulator had said that it would be lifting the import alert 66-40 and move to close out the warning letter issued to the company's Unit-II at Visakhapatnam.
According to the USFDA, an import alert under 66-40 entails "detention without physical examination" of drugs from firms which have not met good manufacturing practices, while an alert under 99-32 is issued to "firms refusing FDA foreign establishment inspection".
After the inspection of the Unit-II in Visakhapatnam in November-December 2016, the USFDA had issued an import alert under clauses 66-40 and 99-32 in March this year. This was followed by a warning letter.
The regulator had, however, exempted several products from the alert.
Divis subsequently said it had filed detailed responses and that it had also taken appropriate remedial measures to address the concerns raised by the USFDA. In July, the regulator lifted the import alert under clause 99-32.
Its Unit-II was again inspected from September 11-19 for full current good manufacturing practices (cGMP) and verification of all corrective actions undertaken.
The company said all previous observations were completed and resolved.
The company received Form 483 (which notifies a management of objectionable conditions) citing six observations after the inspection, Divis said these were only procedural in nature and that it had filed a response within the stipulated time.
While the Divis stock had witnessed a correction after the import alert, it has recovered after the company disclosed that all the previous observations had been resolved.
The counter received a boost from the announcement over the lifting of the import alert.
On the BSE, the scrip shot up Rs 154 or 16.73 per cent to finish at Rs 1074.30. Close to 12.17 lakh shares were traded.
