Torrent Pharma, has announced that its manufacturing facility in Indrad, Gujarat, has received a Form 483 with five observations from the United States Food and Drug Administration (US FDA). The observations were made following a pre-approval inspection (PAI) and a Good Manufacturing Practices (GMP) inspection conducted from June 3, 2024, to June 12, 2024.
In a regulatory filing disclosed after market hours yesterday, Torrent Pharma revealed the outcome of the US FDA inspection. The company emphasized that none of the observations pertained to data integrity issues, which is often a critical concern in such inspections.
“We will respond to the US FDA within the prescribed time-frame and will work in close collaboration with the agency to address the observations at the earliest possible time,” Torrent Pharma stated. The company did not provide specific details about the nature of the observations.
Torrent Pharmaceuticals, the flagship entity of the Torrent Group, holds a prominent position in the Indian Pharmaceuticals Market, ranked 6th overall. The company is particularly strong in the therapeutic segments of cardiovascular (CV), gastrointestinal (GI), central nervous system (CNS), vitamins, minerals, and nutritional (VMN) products, as well as cosmo-dermatology.
The company’s financial performance has been robust, with a notable increase in its consolidated net profit by 56.45% in Q4 FY24, reaching Rs 449 crore compared to Rs 287 crore in Q4 FY23. Additionally, Torrent Pharma’s revenue from operations grew by 10.2% year on year (YoY), totaling Rs 2,745 crore for the quarter ending March 31, 2024.
The inspection and subsequent Form 483 observations come at a time when Torrent Pharma is experiencing significant growth and expansion. The company reassured stakeholders that it is committed to maintaining high standards of manufacturing and quality control, and will take necessary actions to comply with regulatory requirements.
As Torrent Pharma moves forward, the industry will be closely watching how the company addresses the US FDA’s observations and continues to uphold its reputation for quality and compliance in the pharmaceutical sector.
