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Dr Reddy's aims to file 20 DMFs in the US in 2005
Y V Phaniraj, Hyderabad | Saturday, July 17, 2004, 08:00 Hrs  [IST]

Dr Reddy's Laboratories has one of the largest API pipelines in the industry presenting significant growth opportunities. During 2003-'04, the company filed 16 DMFs with the USFDA- the maximum filings for any company in India and taking the total to 56, filed 6 PMFs (Canada) taking the total to 18 and 10 EDMFs (Europe) taking the total to 23. It is aiming to file 20 DMFs in the US in fiscal 2005.

The company's revenues from the segment increased by 20 per cent from Rs 6341 million in 2002-'03 to Rs 7629 million in 2003-'04. About 72 per cent of Dr Reddy's API revenue came from international markets, while 28 per cent came from sales in India. International revenue grew by 20 per cent from Rs 4592 million in 2002-'03 to Rs 5513 million in 2003-'04. Revenue in India grew by 21 per cent from Rs 1749 million in 2002-'03 to Rs 2115 million in 2003-'04.

Within international markets overall growth was driven by Europe, which accounted for 21 per cent of API sales, 25 per cent came from North America and 26 per cent from other regions. It is significant to note that Europe's share in the company's API sales increased from 7 per cent in 2002-03 to 21 per cent in 2003-04. The growth was on account of the launch of Ramipril in mainland Europe, which contributed Rs 1238 million in revenue. On the other hand, there was a decline in revenue from Nizatidine in the US. Sales in North America declined due to lack of significant new product launches. Growth in India was driven by volume expansion in key products of ciprofloxacin, atorvastatin and norfloxacin.

Dr Reddy's has over the years established leadership in synthetic organic chemistry along with developing strong patent navigation skills. The company is expected to continue to step up investments in its pipeline and market developmental activities. The early benefits of these strategic investments will be seen in some new product launches in the USA and Europe.

DRL's bulk manufacturing facilities are located across six units in Andhra Pradesh. These units are built and operated according to the latest systems of cGMP and are inspected and approved by the USFDA and other international inspection agencies for all its major products.

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