USFDA warning letter to Torrent Pharma remains unresolved with latest OAI status

The company said that following the USFDA's inspection and issuance of Form 483, it received a communication from the US drug regulator with the OAI inspection classification for the manufacturing facility at Indrad in the district of Mahesana.

Form 483 is issued to a business when conditions that may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related laws are found during inspection of a manufacturing facility.

Torrent Pharma said it continues to cooperate with the USFDA and will take any necessary corrective action to resolve these issues to the regulator's satisfaction. Torrent Pharma remains committed to complying with cGMP quality standards at all of its facilities.

In India, Cospiaq (Empagliflozin), Cospiaq MetTM (Empagliflozin+ Metformin) and Xilingio (Empagliflozin+ Linagliptin) will be jointly marketed by the company, according to the agreement.

Torrent Pharma shares ended 0.73 percent lower at Rs 1,585.95 on Tuesday.