Torrent Pharma receives USFDA form 483 with observation for Pithampur manufacturing facility

USFDA form 483: Torrent Pharmaceuticals, a leading player in the pharmaceutical industry, announced on Friday that it has received a Form 483 from the US Food and Drug Administration (USFDA) following an inspection of its manufacturing facility located in Pithampur, Madhya Pradesh. The inspection, which is a routine part of the agency’s good manufacturing practices (GMP) oversight, took place from September 16 to September 20, 2023.

In a detailed regulatory filing, the company clarified that the USFDA issued the Form 483 with one observation deemed to be procedural in nature. While the specific details of the observation were not disclosed, the issuance of a Form 483 typically indicates that the inspector found conditions that may represent violations of the Food, Drug, and Cosmetic (FD&C) Act or associated regulations. It serves as a formal notification to the company’s management that they need to address the identified issues.

Torrent Pharmaceuticals expressed its commitment to addressing the observation promptly and effectively. The company indicated that it intends to respond to the USFDA within the stipulated time frame and will work closely with the agency to resolve the matter as quickly as possible. This proactive approach reflects Torrent's dedication to maintaining high standards of quality and compliance in its manufacturing processes.
The Pithampur facility is crucial to Torrent’s operations, as it plays a significant role in the production of a variety of pharmaceutical formulations. The company has made substantial investments in this plant to ensure that it meets the rigorous standards set forth by regulatory authorities, both in India and abroad.

In response to the news of the Form 483, Torrent Pharma’s shares saw a positive reaction on the Bombay Stock Exchange (BSE), trading 2.97 per cent higher at Rs 3,450 per share. This uptick indicates investor confidence in the company’s ability to effectively manage the situation and continue its operations without major disruptions.