In the first drug master file (DMF) approval of its kind, the US Food and Drug Administration (FDA) has approved the sale of metformin hydrochloride tablets which are produced by an Indian company using a pharmaceutical formulation intermediate (PFI), an alternative to sourcing active pharmaceutical ingredients (APIs) which could revolutionalise the conventional pharmaceutical manufacturing model.
Granules India, the company behind the PFI concept, is celebrating the fact that it took the FDA just eleven months to give the green light to its abbreviated new drug application (ANDA) for a drug using PFI, which is based on a "ready to compress" mix of APIs and excipients that can be directly fed into a hopper for compression of tablets.
This concept relies on economies of scale and supply chain management of APIs and excipients and is similar to the bulk drug intermediates model in that drug manufacturers do the final steps of synthesis from outsourced intermediates in order to reduce the overall cost of production.
However, Granules claims that its PFI model results in enhanced productivity, avoidance of granulation bottlenecks, significant lowering of manufacturing costs and less need for regulatory compliance.
"We always wanted to improve on our outsourcing offerings and this has provided us with a strong opportunity to do so," said Krishna Prasad, managing director of Granules India.
"The recognition by the FDA, through this approval, has proven our capabilities to handle commercial granulations of any product, a know-how that has been developed by us over the last ten years of operations."
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 boasts clients like sanofi aventis, Wyeth and Pfizer and its 7,200-tonne PFI facility at Gagillapur near Hyderabad is said be the biggest in the world.
The 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, says the firm.
Granules intends to file DMFs in Europe and will give marketing authorisations to local companies for these, while in the US it has six OTC products pending approval.
According to the company, the EU, which accounts for 8 per cent of its business, has the potential to grow further, while the US, which makes up 70 per cent of its business, will continue to drive growth for Granules.
In the production of metformin hydrochloride, a diabetes drug, the company is partnering with US firm Amneal Pharmaceuticals for the raw material supply.
Granules recently dismissed rumours that it has been negotiating a takeover by Indian API manufacturer Matrix.