The Ahmedabad-based Claris Lifesciences has received the United States Food & Drug Administration clearance for its sterile injectable manufacturing facility near Ahmedabad.
This makes Claris the first injectible product company with completely integrated facility to receive USFDA approval in the country. Claris plans to file 20 more products for USFDA approval during the current year, said Arjun Handa, chief operating officer, Claris Lifesciences.
"For 2006 we filed ANDA for 9 products and hope to get clearance for all soon. By the end of 2007 we plan to file ANDA for 20 more products and in 2008 there will be 30 more products to go for USFDA filing from Claris stable", said Handa.
"Total of 29 products going for USFDA during 2006 and 2007 together holds the market potential in access of $1.1billion, whereas the remaining 30 products that the company plans to push into the US holds the market potential of $1.5 billion," said Handa.
"We see total sales in the US touching around $100 million mark in the third y ear from now." For Claris, this acceptance opens up the doors of the US pharmaceutical market -- the largest in the world at $120 billion, said Handa.
With the manufacturing acceptance in place, the company's products should be available in the US markets by the end of 2007.
In 2007 company has projected revenue of over Rs 700 crore (Rs 7 billion) and hopes cross Rs 1000 crore (Rs 10 billion) mark by the end of next year. Growth plans from 2007 onwards also include a foray into new businesses including Cardiology, Oncology and Biotechnology.
Claris has lined up required funds to support its activities during the next two to three years and prefers to go slow on merger and acquisition route for further expansion, said Handa.
"No point in going for acquisitions and mergers before you become Rs 1000 crore plus company", says Handa. "We will dilute our equity and raise funds may be in next two to three years for future expansion but no plans to approach market in near future", said Handa.
Including the US, Claris Lifesciences is present in 76 countries, and has presence in other regulated markets of Europe, Australia, and New Zealand.
In Europe, the company has successfully filed over 40 Marketing Authorization Applications, entered into business association with some leading European players, and initiated supply of its products, in 2006.
Claris also enjoys a strong presence in the semi-regulated markets including Latin America, South East Asia, Middle East, CIS and Africa.
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