Granules India announced on June 20, 2025, that its API Unit-I facility at Bonthapally, located in Sangareddy District near Hyderabad, has successfully completed a US FDA inspection conducted between June 16 and June 20. The inspection concluded with a single Form 483 observation.
In an exchange filing, the company stated it would address the observation within the prescribed timeline. Granules emphasized that the Bonthapally facility is one of the world’s largest single-site Paracetamol API manufacturing units by volume and also houses manufacturing plants for Metformin and Guaifenesin APIs.
The company assured investors that the outcome will be managed in line with regulatory expectations.
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