Hyderabad-based Glochem Industries Limited (GIL) has received the Certificate of Suitability (CoS) from European Directorate for Quality of Medicines (EDQM) for amlodipine besylate. With the patent rights on the bulk drug due to expire by March 2007, the company expects to be the first source of supply for the drug to European Union countries.

GIL has already been exporting the other salts of amlodipine such as amlodipine maleate to several customers in Europe for the last 6 months, after the expiry of the patent for amlodipine maleate in March 2004. According to a company release, their current customers can now source amlodipine besylate after the patent expiry.

GIL is the second largest manufacturer of amlodipine salts in the world and the biggest in India. It has a share of almost 70 per cent of the Indian market and also a significant market share in Europe, the statement claimed.

The company has applied for CoS for cetirizine dihcl and is in talks with EU customers for export of raloxifene HCl and clopidogrel bisulphate. GIL is in the process of filing the EDMF for these products with various European Health Authorities.

GIL is currently into the manufacture of four bulk drugs viz., amlodipine besylate, cetrizine dihcl, raloxifene HCl, clopidogrel bisulphate with a strong emphasis on regulatory markets.

According to K Subbarao, managing director GIL, the focus on regulatory markets is helping the company to earn better price realisations and resultant profits. GIL, for the year ended 31st March 04, had posted a 75 per cent growth in sales over the previous year touching a turnover of Rs. 18 crore. GIL earns one third of its revenues, from its exports, primarily to the advanced and regulatory markets in Europe.

"The company is now targeting other highly regulated markets like the US, Japan, etc. and is planning to file the DMFs with the US FDA for all the APIs manufactured by it. GIL expects to complete the inspection of its facilities/subsequent approval by US FDA within a year," he said.

The company's customer base includes industry majors such as Cipla, DRL, Ranbaxy, Sun Pharma, Torrent, USV, Lupin, Zydus Cadila, Cadila Pharma, Unichem Labs etc.

Customers in the regulatory market (Europe) include Hexal, Ratiopharm, Merck Generics, Arrow Generics, Stada, Durascan, Teva, among others.