USFDA issues EIR for Torrent Pharma Dahej facility
Ahmedabad: Torrent Pharmaceuticals Limited has announced that the US drug regulator US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (“EIR”) for the company's manufacturing facility at Dahej, Gujarat, and that the inspection has now been successfully closed by the US FDA.
Based on the March 2019 Inspection outcome, the Dahej facility was placed under “Official Action Indicated (OAI)” by the US FDA. The drug regulator had conducted re-inspection of the site in May 2023 from 17-May-23 to 25-May-23 and issued Form 483 with 2 observations.
The updated classification of site is VAI (voluntary action indicated) which indicates that Torrent will start to get approval of filed ANDAs. This will further enhance the company's prospects and foster growth in the US market with its new product offerings.
The Dahej facility manufactures APIs and formulations for Torrent Pharma's international markets.
Read also: Torrent Pharma net profit rises 7 percent at Rs 378 crore in Q1
Torrent Pharma is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. The company specializes in the therapeutic segments of cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology, and anti-infective segments. The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments. The company with ~75% of its revenue in India from chronic & sub- chronic therapies. It has presence in 50+ countries. Torrent has 8 manufacturing facilities, of which 5 are USFDA approved.
Read also: USFDA issues EIR for Torrent Pharma Bileshwarpura facility
