US FDA seeks more records from Divi’s Labs for product nod

US FDA seeks more records from Divi’s Labs for product nod

Mumbai: Divi’s Laboratories said on Wednesday the US Food and Drug Administration (FDA) has made minor observations, primarily about additional records for further improvement for a product which is seeking the regulator’s approval.

Divi’s Labs had an inspection by the US FDA with no major observations for its manufacturing unit near Hyderabad in July, it said.

Drugmakers from India and other emerging markets have run afoul of US regulators over stringent manufacturing standards and processes, potentially crimping their ability to win approvals.

It now takes the FDA more than 30 months to approve a generic drug — where as a year ago it took 25 to 30 months — which is likely to hurt the margins of drug makers, PINC Research’s Sushant Dalmia had told Reuters in April.

Earlier this year, other Indian drugmakers Cadila Healthcare and Aurobindo Pharma too have faced strict inspections by the US regulator for their manufacturing plants.

The purpose of the inspection, which concluded with minor observations about additional records for further improvement, was for product pre-approval and compliance to general current good manufacturing practices, it added.

Cadila Healthcare had said in July, it had received a warning letter from US FDA following a pre-approval inspection of new injectable facility in the western state of Gujarat.

In May, Hyderabad-based Aurobindo Pharma had received a warning letter from the US FDA, based on a field alert report for packaging and labeling compliance for unit-III, seeking a detailed action plan for improvement.

At 11:50 a.m., shares of Divi’s Laboratories, valued at 1,082 crore, were trading at 808, down 0.93% in a weak Mumbai market.