Lupin is trading higher by 1% at Rs 898 after the pharmaceutical company said it has received US health regulator’s approval to sell its generic version of Glumetza HCl ER tablets, a diabetes drug, in the American market.
The stock opened at Rs 899 and hit a high of Rs 901 in early morning deals on the National Stock Exchange.
“The company’s U.S. subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Metformin Hydrochloride extended release tablets (HCl ER) 500 mg and 1000 mg from the United States Food and Drugs Administration (FDA),” Lupin said in a statement.
“Lupin believes that it is the first applicant to file an abbreviated new drug application (ANDA) for Glumetza HCl ER tablets of 500 mg and 1000 mg strengths, and as such will be entitled to 180 days of marketing exclusivity,” it added.
Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
As per IMS health data, Glumetza HCl ER tablets of 500 mg and 1000 mg had sales of nearly $144 million in the US market in 2012-13.
The stock opened at Rs 899 and hit a high of Rs 901 in early morning deals on the National Stock Exchange.
“The company’s U.S. subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Metformin Hydrochloride extended release tablets (HCl ER) 500 mg and 1000 mg from the United States Food and Drugs Administration (FDA),” Lupin said in a statement.
“Lupin believes that it is the first applicant to file an abbreviated new drug application (ANDA) for Glumetza HCl ER tablets of 500 mg and 1000 mg strengths, and as such will be entitled to 180 days of marketing exclusivity,” it added.
Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
As per IMS health data, Glumetza HCl ER tablets of 500 mg and 1000 mg had sales of nearly $144 million in the US market in 2012-13.
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