The Gagillapur PFI facility was re-audited by the FDA and approved, following the filing of an ANDA by one of Granules’ 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 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 tableting block of Granules with a capacity of 12 billion tablets.

Commenting on the development, Mr. Krishna Prasad, Managing Director of Granules India, commented “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.”.

About Granules India Ltd
(BSE: 532482, NSE: GRANULES, Reuters: GRAN.BO)
Granules India Ltd. is a fully integrated pharmaceutical formulations manufacturer with the world's largest 'granulation' capacity. The company manufactures several strategic Active Pharmaceutical Ingredients (APIs) and multiple Pharmaceutical Formulation Intermediates (PFIs), which are distributed in 35 countries. It is foraying into manufacturing of tablets with a capacity of 6 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).

For further details please contact:

Granules India
Mrs.N.Madhavi
Cell: 91 98663 20405

Adfactors PR Pvt. Ltd; Mumbai
Rakesh Sharma/ Shalaka Parab
Phone: 022- 22813565
Email: rakesh@adfactorspr.com / shalaka@adfactorspr.com