'Granules'' facilities receive US FDA approval

Mumbai, May 14 (UNI) Granules India Ltd (GIL), a fully integrated pharmaceutical company with specialisation in Pharmaceutical Formulation Intermediates (PFI), today announced the approval of its facilities by the US Food&Drug Administration (FDA).

The Gagillapur PFI facility was re-audited by the FDA and approved, following the filing of an ANDA (Abbreviated New Drug Application) by one of Granules' customers in the United States.

Managing Director, GIL, Krishna Prasad, 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''.

The new Active Pharmaceutical Ingredients, API facility at Bonthapally, manufacturing 12000 MT of Acetaminophen / Paracetamol API was audited and approved by the FDA following a special request made by Granules 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 tabulating block of Granules with a capacity of 12 billion tablets.

GIL manufactures several strategic APIs and PFIs, which are distributed in 35 countries. It is foraying into manufacturing of tablets with a capacity of six billion tablets per annum. This facility will strengthen its presence in the pharma outsourcing space as it will have capabilities of offering a wide range of products beginning from APIs to finished dosages (coated/uncoated).

UNI