Sun Pharma to file for generic drugs in US

Sun Pharmaceutical Industries, the country's most valued drug maker, aims to file 30 applications in the US for manufacturing and marketing of its generic products, company CMD said.

The company would file these applications along with its US-based subsidiary Caraco, which is facing trouble due to non-compliance of current good manufacturing practice of the US drug regulator.

"This year too, we intend to file 30 ANDAs in the US across the two companies," Sun Pharma CMD Dilip Shanghvi said in his speech to the shareholders of the company during the annual general meeting held last week.

We continue to spend for product development and file new products from these sites in India and the US, he said.

Between Sun and Caraco, 111 products are pending with the US FDA (Food and Drug Administration).

An abbreviated new drug application (ANDA) is an application for a generic drug approval in the US for an existing licensed medication or approved drug.

The USD 30 billion-plus US generic market, the largest generic market in the world, is of great interest to all pharma companies across the world with global aspirations.

Last year, generics accounted for 71 per cent of the US pharma market by prescription.

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