Granules unit in Hyderabad, one of the largest globally for paracetamol API, under U.S. FDA scanner  

Generic drugmaker Granules India’s active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA).

The Bonthapally facility is one of the world’s largest single-site paracetamol API manufacturing plants by volume. Along with paracetamol APIs, the company has established Metformin and Guaifenesin API manufacturing plants in the same facility, Granules India said in an intimation to the stock exchanges on Friday.

The U.S. FDA had inspected the facility, located in Sangareddy district, from June 16-20 and issued Form 483 with one observation. The company said it will respond to the observation within the stipulated time.