Granules India’s Hyderabad facility inspection has been classified as ‘Official Action Indicated’ (OAI) by USFDA. 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 Hyderabad in compliance with its expectations within a short time.

Earlier, the USFDA had issued Form 483 with 6 observations for said facility. 

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).