 "Torrent Pharma")
Drug firm Torrent Pharmaceuticals Limited on Thursday announced that the US drug regulator US Food and Drug Administration (USFDA), 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 USFDA, said the company.
Based on the March 2019 Inspection outcome, the Dahej facility was placed under "Official Action Indicated (OAI)" by the USFDA. OAI means "objectionable conditions were found and regulatory, administrative sanctions by FDA are indicated" during inspections.
The drug regulator had conducted a re-inspection of the site in May 2023 from May 17 to May 25 and issued Form 483 with two observations, said the company.
Form 483 is issued to a firm's management after an inspection when the investigator has observed any conditions that in its judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The updated site classification is Voluntary Action Indicated (VAI), which indicates that Torrent will start getting approval for filed Abbreviated New Drug Applications (ANDAs). This will further enhance the company's prospects and foster growth in the US market with its new product offerings, it added.
The Dahej facility manufactures Active Pharmaceutical Ingredients (APIs) and formulations for Torrent Pharma's international markets.
