Kopran Ltd has received drug marketing approval from the European Union for roxithromycin, a macrolide antibiotic, manufactured at its bulk drug plant at Mahad in Maharashtra, a source close to the company said here.
This approval will help Kopran make forays into one of the biggest regulated markets in the world.
Kopran and its German partner Helm have already entered into a long-term agreement with leading generic companies to sell roxithromycin in Europe and Scandinavia where the product is already off patent. In France, roxithromycin will go off patent in August next year.
Germany and France are the largest generic markets in the European Union from where Kopran would be benefited with higher price realizations that EU markets traditionally offer.
Kopran has the advantage of being the early entrant in the highly regulated EU market where stringent documentation requirements are expected to hinder proliferation of competition.
The annual demand of roxithromycin in the EU is estimated at 35 metric tonnes and growing at 20 per cent per annum. In the first year itself, Kopran expects to sell 10-12 tonnes worth around US$ 2.5 million.
Roxithromycin is the second drug of Kopran that has been approved for sales in the EU, the first being Atenolol. Kopran has been awarded a certificate of suitability for Atenolol three years ago.
The source said Kopran is shortly expected to receive another certificate of suitability in EU for two of its sterile cephalosporins - ceftriaxone and cefotaxime. Kopran has expanded the capacities of sterile cephalosporins at its Mahad plant from 30 tonnes to 48 tonnes per annum with an additional investment of Rs five crore.
Next year, Kopran plans to manufacture in the same plant two more sterile cephalosporins - ceftazidine and cefpirome. The world markets for ceftriaxone and cefotaxime active pharmaceutical ingredients are estimated at $ 80 million and $50 million respectively, the source claimed.