The New Delhi-based Promed Exports Pvt Ltd, an export oriented company into sterile manufacturing, is readying to cash in on the fast growing generic sterile market in US and European Union with focus on ophthalmic drugs segment.

The company, which claims as the second largest pharma company in the eye care market of Russia, is preparing almost 15 Abbreviated New Drugs Applications (ANDAs) with a target to complete the filings within next two years. Among the ANDAs, 10 filings will be for the ophthalmic products which are expected to go off patent in next three years.

Almost 15 ophthalmic drugs are going off patent in US and Europe before 2012 and these products will grossly have a sales value of nearly US$ 2.5 billion. Of this, almost USD 1 to 1.5 billion worth market is opening up in US. The company is planning to grab the market by collaborating with some of the big generic companies in US and Europe.

"Globally, there are very few pharma companies having sterile production capacity and we have found an opportunity, especially in the growing US and Europe generic market by 2010-2011," said Deepak Bahri, president, Promed Exports Pvt Ltd. However, the entry barriers to these countries are getting more rigid and the company is planning to go for approval from the regulators with all the latest facilities, he added. Currently Indian companies like Piramal Healthcare, Cipla, Indoco Remedies and FDC Ltd are present with their ophthalmic products in the regulated market.

The company is currently doubling its capacity of its plant in Himachal Pradesh, which has a unique Blow-fill-seal technology, from the current annual capacity of 90 million units within next 12 to 18 months and has earmarked Rs 40 crore for the project. The company is planning the expansion projects with an allocated investment of Rs 125 crore for the next three to five years. Plans are to leverage the internal accruals and term loans for the initial projects and then go for a fund raising effort through private equity firms, informed Bahri.

The European Medicines Agency (EMEA) is expected to inspect the current facility within next three months and the plant will go through US Food and Drug Administration (FDA) in 2009 itself, he averred. The company has already acquired CE Mark certification for products to be exported to Europe.

The Rs 80 crore Promed Exports, which devotes 8 to 9 per cent of its revenue on research and development, is currently working on 45 new products in the sterile segment. The company aims to touch a turnover of Rs 500 crore by 2012-13.