Home / Companies / News /  USFDA issues Form-483 with 1 observation to Torrent Pharma

Torrent Pharmaceuticals on Friday said the US Food and Drug Administration completed company’s Pre-Approval Inspection (PAI) of Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat. USFDA has issued Form 483 with one observation after inspecting its Gujarat-based manufacturing facility.

The US Food and Drug Administration (USFDA) conducted the pre-approval inspection of the Torrent Pharma Bileshwarpura-based plant from March 13-March 17.

“The USFDA conducted Pre-Approval Inspection [PAI] of our Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat from 13-Mar-23 to 17-Mar-23. At the end of the inspection, we have been issued a “Form 483" with 1 observation, which is procedural in nature," said Torrent Pharmaceuticals in its regulatory filing.

 "We will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observation at the earliest.," the regulatory filing added.

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection, when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Torrent Pharma said its consolidated net profit increased by 14 per cent to 283 crore in the third quarter ended December 31, 2022.

The drug firm had reported a net profit of 249 crore in the October-December period of previous fiscal.

Net sales increased to 2,459 crore in the quarter under review as against 2,092 crore in the year-ago period, the company said in a regulatory filing.

The company's board had declared an interim dividend of 14 (280 per cent) per share of 5 each.

The company's scrip ended 1.33 per cent down at 1,532.25 on BSE.

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