Granules India has started commercial operations at its new pharmaceutical formulation intermediates (PFI) facility at Gagillapur near Hyderabad. The new unit with a capacity of 7,200 metric tonnes per annum is said to be the world's largest commercial PFI plant.
Granules has invested Rs 30 crore (€6m) in the fully automated plant, designed to conform to the highest standards of current Good Manufacturing Practice (cGMP). "With the inauguration of the new plant, Granules now moves on to the next level in the pharmaceutical value chain," said C Krishna Prasad, the company's managing director.
The new PFI facility has two granulation lines, for high shear and fluidised granulation and produces large batch size PFIs that will result in significant savings in costs for customers, according to the firm.
Over the last several years, Granules has pioneered the manufacture and propagated the use of PFIs for the generic prescription drug and branded and generic over-the-counter (OTC) medicine markets.
The company is predicting that pharmaceutical multinationals will switch over to the purchase of PFIs instead of Active Pharmaceutical Ingredients (APIs) and will relies on dedicated companies like Granules for their PFI requirements.
Granules explains that the PFI concept is similar to the bulk drug intermediates model, in which bulk drug manufacturers do the final steps of synthesis from outsourced intermediates in order to reduce the overall cost of production. The company claims to be a market leader in the manufacture and sale of directly compressible granules of multiple APIs, in the form of PFIs.
The company manufactures and markets its PFIs under the Compresso brand name as value-added products to various multinational pharmaceutical companies in the regulated markets as a penultimate step before tabletting.
Usage of commercial PFIs results in multiple benefits to the pharmaceutical formulation companies in the regulated markets, said Granules, including "enhanced productivity, avoidance of granulation bottlenecks, significant lowering of manufacturing costs [and] reduced regulatory compliance."
"The new plant is the perfect launch pad for the next phase of accelerated growth of Granules. It also forms the cornerstone of the company's growth strategy for the future, which aims at becoming an integrated pharmaceutical company," Mr Prasad added.