The Mumbai-based pharmaceutical major, USV Ltd, is all set to tap the US generics market and will submit 10 Abbreviated New Drug Applications (ANDA) in various segments to US FDA by the middle of this year. USV will also submit 5 ANDAs in Europe.
So far, the Rs 500 crore odd pharma major was concentrating only on exports of APIs and branded generics to the regulated markets.
The company's JV partner in US, Indicus Pharma LLC will handle the regulatory affairs for entering the US. Indicus is currently looking for a marketing partner for USV in US. USV has earmarked about Rs 40 crore for the US foray.
Speaking to Pharmabiz, Prashant Tewari, managing director, USV, said, "The ANDAs are likely to be submitted by June-July, this year. Once we get the approval, we may make a marketing collaboration in US. It may be either a US or an Indian company." However, he refused to name the segments where USV would submit the ANDAs.
Apart from US, the company is also submitting 5 ANDAs in Europe this year. The company is in the process of identifying a suitable partner for entering the European market. In the API segment, the company will file 25 more DMFs in the regulated markets within next two years, said Tiwari.
The company has a turnover of Rs 500.4 crore (USD 114 million) in the financial year ended March '05. Domestic sales contribute 67 per cent of company's business and the rest is from exports of APIs and branded generics to various countries. USV's plants have been approved by US FDA and TGA Australia.
USV Ltd is a major player in diabetes and cardiology segments. It markets about 32 brands in these segments that contribute to 52 per cent of its turnover. USV, top ranked in diabetes care in India, has entered into an agreement with B Braun, a $ 2.3 billion German healthcare company, for marketing of blood glucose monitoring system known as Quicktest - U.