The German Health Authority (GHA) has completed the quality audit at the MTPA facility of Granules India located at Gagillapur near Hyderabad. The new PFI 7200 MTPA plant, which is one of the largest in the world, has been audited by an international regulatory agency for the first time.
With the GHA approval to the facility, which is awaited, the company can export its products to Europe and enlarge its presence in these markets significantly. The company relates this achievement to its large capacity, R&D capabilities and having the world's largest batch size of 6 MTs.
So far these markets were served from the company's Jeedimetla plant near Hyderabad with its limited capacity and also restricted ability to introduce new products that are required by its European customers.
The facility, systems and procedures at Gagillapur were found compliant with the requirements of the German Health Authority. The company is seeking similar approvals from other international regulatory bodies such as the Australian TGA and US FDA, which are expected to be obtained in the near future.