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The Hyderabad-based Matrix Laboratories has received the United States Food and Drug Administration's approval for fluconazole active pharmaceutical ingredient.
Fluconazole is the generic version of Pfizer's $1 billion anti-fungal drug Diflucan, whose patent in the US expires on January 29, 2004.
Following the approval, Matrix Labs will supply the API to Ranbaxy and US-based Genpharma, a generics arm of Merck, whose abbreviated new drug applications were approved by the US FDA.
Matrix has been supplying fluconazole API to Europe and Canada. This is the second US FDA approval for Matrix, which had earlier got a similar approval for Acyclovir.
Matrix Labs, which has been riding on the exports of Citalopram API to Europe with non-infringing process patent, has filed 10 overseas process patents in different therapeutic segments in the first quarter of the current fiscal. It includes another novel improved process patent for Citalopram.
Matrix Labs recorded a 51 per cent jump in net profit at Rs 30.70 crore (Rs 307 million) on sales of Rs 127 crore (Rs 1,270 million) for the first quarter ended June 30, 2003, against a net profit of Rs 20.29 crore (Rs 202.9 million) and sales of Rs 50.69 crore (Rs 506.9 million) in the same quarter last year.
The annualised earnings per share works out to Rs 99.80 on the expanded equity ( after the merger of Vorin Labs and Medicorp Technologies with it) of Rs 12.30 crore (Rs 123 million). Of the total sales in the first quarter, exports constituted about 60 per cent.
"Our strategy to broadbase the product mix is paying off with good contribution from several new products into the regulated markets, while sales of Citalopram, our blockbuster drug, continues to grow. Of the total increase in sales in the latest quarter, Citalopram contributed 36 per cent, while the rest came from other products," N Prasad, chairman and chief executive officer, said.
"We have started selling Citalopram to more customers in Europe. We have also tied up with a number of generic companies in the US for Citalopram and commercial supplies will begin after the patent expires in 2004," Prasad added.
The Rs 400 crore (Rs 4,000 million) company, which has thus far filed seven drug master files in the US, expects to file 10 DMFs during the current year.
The company's product pipeline consists of 25 drugs for supply to the regulated markets before 2008, as and when the patents expire. The company also hopes to get about 10 per cent of the sales through contract manufacturing during the current fiscal.