Key Takeaways
- The Dahej facility received an updated VAI classification, allowing Torrent Pharma to pursue ANDA approvals.
- US FDA issued an Establishment Inspection Report (EIR) and a Form 483 with two observations during re‑inspection.
- The facility manufactures APIs and formulations for international markets, positioning the company for growth in the US.
Mumbai: Pharma major, Torrent pharma on Thursday said 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.
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 May 17, 23 to May 25, 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.
