Granules India gears up to launch new formulations

City-based Granules India Limited, a leading pharmaceutical formulations intermediates (PFIs) and active pharmaceutical ingredients (APIs) company in the country, is gearing up to launch new formulations during the current financial year.

The company hopes to file several drug master files and abbreviated new drug applications (ANDAs) in the pain management and life style-related segments.

It is also looking to foray into neutraceuticals (800 mg and above). It is also working on a niche segment of taste-masked PFIs of various APIs, which can be compressed into palatable quick "� dissoluble tablets, mainly, for pediatric and geriatric segments.

The company sees prospects for rapid growth in the outsourcing area, and expects to clock over Rs 140 crore turnover this year with exports contributing over 55 per cent. For the 12-month period ended March 2004, the company recorded Rs 100 crore in turnover and exports constituted around 50 per cent.

Granules is the first company in the country to pioneer the concept of offering directly compressible granules (DCs) of multiple APIs as PFIs on a commercial scale. The DCs are marketed under the brand name Compresso in the US, Australia, Europe, Canada and other regulated markets.

The company is looking at Southeast Asian markets for expansion. "PFIs are pre-processed and value-added APIs ready to be compressed into finished dosages. They can be of single APIs or in a combination of more than one API. We have several PFIs of various APIs. We continuously add more products to meet the ever-growing demands of our international customers and in the last fiscal we added eight new PFIs. We are at present working on several more new formulations and we expect to launch them during this financial year," N R Ganti, director of Granules India, told Business Standard.

The company manufactures and markets DCs of Guaifenisin, Ibuprofen, Menformin, Paracetamol (several grades) and also DCs of combination APIs with Paracetamol.

APIs mostly for in house consumption and some quantities are sold both in domestic and International markets as bulk actives. They are Guaifenisin, Metformin, Methocarbomal, Oxymetazoline, Paracetamol and Primaquin Phosphate.

The total production during the last fiscal was around 3,500 tonnes inclusive of 2,700 tonnes of PFIs as exports. The company's current installed capacity is around 12,300 tonnes. It makes paracetamol at its Bonthapalli plant (2,760 tonnes), granules and APIs at Jeedimetla plant (2,376 tonnes) and granules solely at its Gagillapur plant (7,200 tonnes).

The Gagillapur plant, an export-oriented unit, is the world's largest stand-alone granulation facility. It was commissioned last year at an investment of Rs 28 crore. Granules is the only company apart from Mallinckrodt, Rhodia and Attaby to have the three most important regulatory approvals from US FDA, German Health Authority and Australian TGA. It produces PFIs for both generic prescription and over-the-counter (OTC) branded and generic formulations.

This year the company expects the PFI production to be around 4,500 tonnes. Most of the API production goes into PFI manufacturing, Ganti said. The total potential for outsourced granulation for products is nearly 3,50,000 tonnes per annum in the world.

A major portion of them is for the consumption in the regulated markets, he observed. Last year, the company unveiled its plans to set up new plants at a cost of around $20 million. Ganti said that as part of backward integration for strategic APIs, the company would set up a modern paracetamol API plant with an annual capacity of 6,000 tonnes.

The unit is to come up at the existing facility in Bonthapally. The company is also setting up a state-of-the-art finished dosage plant at Gagillapur which can produce around six billion tablets a year.

"The company is in the process of arriving at the final costs and determining the means of finance. We expect to start construction during this year and complete it by next financial year," he said.