Torrent Pharma Faces USFDA Scrutiny

Torrent Pharmaceuticals reported that the US FDA issued a Form 483 with one procedural observation following a routine inspection at its Pithampur manufacturing facility. The company will respond within the stipulated timeframe and aims to resolve the issue promptly. Torrent Pharma's shares surged by 2.97% on BSE.

Torrent Pharmaceuticals on Friday revealed that the US health regulator, USFDA, has issued a Form 483 with one observation after a routine inspection of its Pithampur-based manufacturing facility.

The US Food & Drug Administration conducted a routine GMP inspection of Torrent's formulation manufacturing plant at Pithampur, Madhya Pradesh, between September 16 and 20, according to a regulatory filing by the company.

The observation cited in the Form 483 is procedural in nature, as per Torrent Pharma. The company has committed to addressing the observation promptly and will submit its response within the USFDA's prescribed timeframe.

As defined by the USFDA, a Form 483 is issued to a company's management at the conclusion of an inspection when any conditions potentially violating the Food Drug and Cosmetic (FD&C) Act and related Acts are observed.

Following this development, Torrent Pharma's shares witnessed a notable increase, trading 2.97 percent higher at Rs 3,450 per share on BSE.

(With inputs from agencies.)