Granules India Ltd has provided a significant update regarding the recent US FDA inspection of its Gagillapur facility in Hyderabad, Telangana. As per the company’s communication on September 7, 2024, the FDA issued a Form 483 with six observations, and the inspection was classified as “Official Action Indicated” (OAI).
In response, Granules India has diligently addressed all FDA observations. The company has taken proactive steps by engaging with external experts to conduct a comprehensive evaluation of the Gagillapur facility. This evaluation aims to further enhance and improve the facility’s operations in line with US FDA standards.
Granules India is committed to working closely with the US FDA to resolve the observations and believes that these efforts will result in the facility meeting the FDA’s compliance expectations. The company is confident that the necessary improvements will lead to a successful reapproval of the Gagillapur facility in the near future.
In the meantime as of 2:44 PM, Granules India shares were trading 4.22% lower at Rs 569.95 on the NSE.
