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      Lupin Pharma Might get USFDA Approval for 6-10 Drugs by March

      Posted AtReuters.com

      Pharma major Lupin expects to add six to 10 new U.S. FDA approvals by the end of the 2011 fiscal to its present pipeline of 45 approvals, its managing director Pharma major Lupin expects to add six to 10 new U.S. FDA approvals by the end of the 2011 fiscal to its present pipeline of 45 approvals, its managing director.

      "The U.S. FDA regulations have become further stringent but the number could still be more than 10 during the rest of the year," Kamal Sharma told Reuters in a telephone interview.

      The Mumbai-based drugmaker, which spent about 4.43 billion rupees as capex in FY10, primarily to set up a new unit at Indore, sees a similar capex in the current fiscal, he added.

      "We will spend about 400 to 450 crore (4 - 4.5 billion rupees) as capex in the current year... for the new therapy areas," he added.

      Earlier in the day, Lupin reported a 40 percent rise in consolidated quarterly net profit to 1.96 billion rupees on net sales of 13.12 billion rupees meeting the street estimates.

      A Reuters' poll of 14 brokerages had forecast a consolidated quarterly net profit of 1.94 billion rupees on net sales of 13.66 billion rupees for Lupin.


      A strong performance posted by Lupin in the April-June period in the U.S. and European markets is expected to continue throughout the financial year, Sharma added.

      Formulations sales in the U.S. and European markets grew by 40 percent to 4.96 billion rupees in the first quarter, it said in a statement.

      "We have stuck to select products," he stated. "...And spent a substantial amount on developing supply chain in these advanced markets; which puts us ahead of others."

      The pricing regulations and forex fluctuation challenges faced by drugmakers in Japan would not affect Lupin's growth in this fast-paced north Asian market, he added.

      "The Japanese government, after every three years, discounts the prices of certain key drugs," he said. "This time, the prices were reduced by 16 percent instead of 12 percent typically."

      Lupin has been operating in Japan for only two and a half years and hence, its product line has not come under the price-cut regime as on date, he added.

      The drugmaker had acquired Kyowa Pharmaceutical Industry in the year 2007 to enter the Japanese market.

      The unit clocked a revenue of 1.3 billion rupees during the April-June period while India sales stood at 4.2 billion rupees, Lupin said in a statement.

      The firm would spend about 7.5 percent of its net sales in FY11 on research and development activities. It spent 3.5 billion rupees year, he said.

      Shares of Lupin, after reaching a day's high of 1,985 rupees, closed at 1,926 rupees on Wednesday, down 1.45 percent in a Mumbai market that ended down 0.67 percent.

      July 30, 2010


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