With reference to communication dated September 07, 2024 about the US FDA inspection of the Company’s facility at Gagillapur, Hyderabad, Telangana and the issuance of Form 483 with 6 observations, Granules India has further informed that the US FDA has classified the inspection as ‘Official Action Indicated’ (OAI). The Company has responded to all the observations issued by the US FDA. Additionally, the Company has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility. This activity is undertaken in consultation with external subject matter experts. The Company will work with the US FDA on this activity and is confident that it will result in the US FDA approving the Company’s facility at Gagillapur in compliance with its expectations within a short time. This is for information and dissemination to the members of the exchange.
The above information is a part of company’s filings submitted to BSE.
