USFDA lifts import alert on Divi's Vizag plant

No major financial losses for the firm due to the import alert as regulator had spared most products from action

The US Food and Drug Administration (USFDA) informed Hyderabad-based Divi's Laboratories Limited that it will be lifting import alert 66-40 and moving to close out the warning letter issued to the company's Unit-2 at Visakhapatnam.

With the latest communication the import alert issued on Divi's Vizag facility on two technical grounds comes to an end relatively quickly.

The company has not suffered any significant financial losses on account of the import alert in the past seven months as the US drug regulator had exempted most of the products from its action citing their importance for an adequate supply of drugs made from these active ingredients in the US market.

Earlier in July, the US drug regulator had lifted import alert 99-32, which pertains to an alleged refusal of inspection of the premises by the company. The import alert 66-40 relates to the issues found in manufacturing compliance.

In March, Divi's facility came under the import alert after US drug regulator had not satisfied with the remedial actions taken by the company in connection with the Form 483 observations issued by the visiting inspection team during its audit from November 29-December 6 last year.

Unlike in other recent instances where the USFDA had taken punitive actions against the Indian pharma companies, Divis was able to quickly come out of the regulatory scrutiny.

The company shares jumped 16.73 percent at Rs 1,074.30 on the Bombay Stock Exchange on Thursday.