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Granules sets timeline for enhanced capacity unit

Our Bureau

Gets US FDA approval for two facilities

Hyderabad May 14 Granules India Ltd (GIL) is set to commission its enhanced capacity tablet unit here by June end. The capacity would be 6 billion tablets per annum.

With plans to begin commercial scale operations in August, GIL hopes to reach at least 60-70 per cent of the capacity, according to Mr C. Krishna Prasad, Managing Director.

In the second year, plans are afoot to double the capacity to 12 billion tablets per annum. GIL, an active pharmaceutical ingredients (API) manufacturer, has tied up funds for the expansion initiative raising about $25 million by bringing in strategic investors recently, he told Business Line.

The company has also obtained audit approval for its manufacturing facilities located at Gagillapur on the outskirts of the city inspected by the US Food and Drug Administration (FDA), last week.

The Gagillapur PFI (pharmaceutical formulation intermediates) facility was re-audited by the FDA and approved, following the filing of an ANDA by one of the company's customers in the US.

The Bonthapally new API facility, manufacturing 12,000 tonnes per annum (tpa) of acetaminophen/paracetamol API was also audited and approved by the US 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 tpa 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, Mr Krishna Prasad, Managing Director of the company, said: "The approval of our acetaminophen facility by the US 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."

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