Torrent Pharmaceuticals’ Oral-Oncology manufacturing facility receives one observation from USFDA after pre-approval inspection

The US Food and Drug Administration finished Torrent Pharmaceuticals’ Pre-Approval Inspection (PAI) of its Oral-Oncology manufacturing facility in Bileshwarpura, Gujarat, on Friday. Following an inspection of its Gujarat-based manufacturing plant, the USFDA issued Form 483 with one observation.
The US Food and Drug Administration (USFDA) performed the pre-approval inspection of the Torrent Pharma Bileshwarpura-based plant from March 13-March 17.
“From March 13 to March 17, the USFDA performed a Pre-Approval Inspection [PAI] of our Oral-Oncology manufacturing facility in Bileshwarpura, Gujarat. “At the conclusion of the inspection, we were issued a “Form 483″ with one procedural observation,” Torrent Pharmaceuticals stated in its regulatory filing.

“We will respond to the USFDA within the specified timeline and work closely with the USFDA to address the observation as soon as possible,” the regulatory filing continued.
According to the USFDA, Form 483 is given to a company’s management at the end of an inspection if the investigator notices any conditions that may constitute violations of the Food, Drug, and Cosmetic Act and related Acts.

Torrent Pharma reported a 14 percent rise in consolidated net profit to 283 crore in the third quarter ended December 31, 2022.

In the previous fiscal year’s October-December period, the drug company recorded a net profit of 249 crore.

According to a regulatory filing, net sales rose to 2,459 crore in the current quarter from 2,092 crore the previous year.
The board of directors of the business declared an interim dividend of 14 (280%) per share of 5 each.

On the BSE, the company’s stock closed 1.33 percent lower at 1,532.25 rupees.