Granules India Ltd has announced the approval of its facilities in the recently conducted audit by US FDA. The Gagillapur PFI facility was re-audited by the FDA and approved, following the filing of an ANDA by one of the company's customers in the United States.

The Bonthapally new API facility, manufacturing 12000 MT of acetaminophen/paracetamol API was audited and approved by the FDA following a special request made by the company to schedule the inspection of this plant.

The Gagillapur facility has the capacity to manufacture 7,200 MTPA of PFI and is the site for the new tableting block of the company with a capacity of 12 billion tablets.

Commenting on the development, Krishna Prasad, managing director, said, "This approval of our acetaminophen facility by the FDA will help us get into high-value combination products of acetaminophen at the formulations level apart from giving the comfort to our customers that Granules adopts the highest standards of quality management even for a product like acetaminophen where having an FDA inspected plant is not a pre-requisite to be a supplier."