Mumbai, Apr 7: Morepen Laboratories has received the USFDA approval for its bulk drugs plant at Parwanoo in Himachal Pradesh for manufacturing loratadine, a non-sedative, anti-allergic drug. The development is expected to have a positive impact on the company's bottomline given that international prices of loratadine range between $8,000 and $10,000 per kg.A release said that Morepen expects around 50 per cent net margin on the sale of loratadine in the European and American markets. Morepen has an installed capacity of six tonnes per annum and the company expects around 50 per cent of its turnover to come from this product in the years to come. Morepen Labs, the second-largest manufacturer of loratadine globally, had filed its drug master file (DMF) in September 1997. Morepen had acquired the lab technology for manufacturing loratadine from Techquim Establishment in Switzerland in June 1993. The drug is covered by patents in the US, Canada, and Western Europe. The US patent expires in 2002, while inCanada and Europe, the patents expire in January 2001 and June 2001 respectively.
Morepen Labs exports loratadine to 22 countries spread across South America, East Europe and Asia. Loratadine is the fifth-largest selling drug in the world and enjoys over 50 per cent market share among all anti-histamines. The market size for the product is estimated to be over $2 billion (Rs 8,500 crore), and is growing at over 51 per cent.
Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.
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