The Hindu Business Line : Glochem Ind gets EU nod for amlodipine besilate

GLOCHEM Industries Ltd (GIL), the city-based pharmaceutical company specialising in amlodipine salts, has announced that it has received the certificate of suitability (COS) from the European Directorate for Quality of Medicines for amlodipine besilate.

In a press release here, the company said the certificate would enable it to export amlodipine besilate to its customers in the European Union countries on the expiry of the patent for the product in March 2007. The company expects that the COS would make it the first source of supply for most of the generic companies in the EU countries.

The company has already been exporting the other salts of amlodipine such as amlodipine maleate to several customers in the Europe for the last six months, as the patent for amlodipine maleate has expired in Europe in March 2004.

The company said it has also applied for COS for another active pharmaceutical ingredient - cetirizine dihcl - and expects to receive the COS for this product shortly. With this, the company would be having the COS for all the European Pharmacopoeial products manufactured by it. Currently, GIL is in discussions with the customers from EU countries for export of the other two bulk drugs being manufactured - raloxifene HCl and clopidogrel bisulphate. It is in the process of filing the drug master files for these products with various European Health Authorities.

The current customers of the company include industry majors such as Cipla, Dr Reddy's Labs, Ranbaxy, Sun Pharma, Torrent, USV, Lupin, Zydus Cadila, Cadila Pharma and Unichem Labs in the domestic market. Customers in the regulatory market (Europe) include Hexal, Ratiopharm, Merck Generics, Arrow Generics, Stada, Durascan and Teva among others.

Commenting on the development, the GIL Managing Director, Mr K. Subba Rao, said, "Taking its strengths forward, the company, now, targets the more advanced regulatory markets such as the US, Japan, etc and is planning to file the DMFs with the US FDA for all the APIs manufactured by it. Considering the interests shown by some of its customers in the US towards sourcing of APIs from the company, GIL expects to complete the inspection of its facilities by US FDA followed by its approval within an year from now."

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