The Hyderabad-based Granules India plans to target new customers in regulated markets in the US and Europe in the pharmaceutical formulation intermediates (PFIs) segment.
Granules is strengthening its marketing force in the New Jersey, USA, besides South America, Brazil, Canada and UK. North America and Latin America will also remain key markets for the company in future. It will particularly target South America for PFIs.
"Our unique positioning in the pharmaceutical value chain ensures a unique proposition for global Pharma giants looking at outsourcing," C Krishna Prasad, MD, Granules India, told Pharmabiz.
Seventy per cent of Granules business comes from the US and EU accounts for about eight per cent, Asia and India account for another eight per cent and rest comes from other markets. EU has potential to grow further, while US markets will continue to drive growth for Garnules, he added.
The company along with Amneal Pharmaceuticals LLC (United States) have recently obtained a US FDA approval of the ANDA of metformin hydrochloride tablets of 500 mg, 850 mg and 1000 mg. This is the first time that the US FDA has approved an ANDA with a PFI (Pharmaceutical Formulation Intermediate).
Granules is also in the process of strengthening its infrastructure facilities. It has commissioned a cGMP compliant 8000 TPA paracetamol plant in March 2006 at Bonthapally, at the outskirts of Hyderabad, Andhra Pradesh. It has facilities in Gagillapur (granulation, sold dosage forms and R&D) and Jeedimetla in Hyderabad. It is also developing a new tableting unit at Gagillapur, which will have a state-of-the-art compression and coating unit. The company is likely to invest about Rs 50 crore for setting up this unit. The facility is expected to have a capacity of producing 12 billion tablets a year and will be among the largest in Asia in terms of capacity. The coating capacity will be 3 billion per year initially and can be expanded to 6 billion per year. The entire facility will be ready by January 2007, Prasad said.
Granules is also establishing a new facility in the Jawaharlal Nehru Pharma City in Parawada near Visakhapatnam in an area of 18 acres. The company plans to produce APIs. Land has been acquired and construction of the facility is yet to begin. The company in the near future proposes to raise funds through private equity and FCCBs and is evaluating these options at present. It will utilise internal accruals to meet part of its funding needs for meeting its expansion.
The company plans to roll out half a dozen OTC and prescription products in next two years. OTC segment will concentrate on paracetamol and ibuprofen, while prescription segment will cover metformin and paracetamol. At present, paracetamol contributes about seventy per cent of its revenues. ANDA filings will show progress within next one year. The company may also focus on dossier and formulations development. It may look at high-end nutraceuticals also. It will also work on immediate and sustained release dosage forms in future.
Recently the company has received US FDA approval for metformin hydrochloride tablets of 500 mg, 850 mg and 1000 mg. This will help the company recognized as more than an OTC player and has opened up a new vista of business opportunities. The company, which achieved net sales of Rs 180 crore during 2005-06 is hoping to achieve about thirty per cent growth in 2006-07. The company will register quantum jump during 2007-08. The company will also triple its technical team by next year, and expand its marketing force exponentially in next few months, he added.
Outsourcing is gaining prominence across the world, and now pharma companies have realised that they should focus on key activities and the rest should be outsourced from efficient partners. India has enormous advantage as it can offer better soft skills, which account for about 60 per cent of the total manufacturing cost. The company is looking at various partnership models in APIs and intermediates. It is open to talks with companies in US, Europe and China, and in some places, the talks are in advanced stage. The company may look at complete takeovers too, on suitability, he said.