Lupin gets tentative approval for glycemic control drugs; stock makes a U-turn after hitting 52-week high

Lupin shares on Friday clocked a 52-week high on Friday after the drug maker received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Dapagliflozin and Saxagliptin tablets to market a generic equivalent of Qtern tablets of AstraZeneca AB. The stock gained by as much as Rs 32.1, or 2.3 per cent, to Rs 1,430 apiece on BSE, surpassing an existing peak of Rs 1,422.1 registered the previous day.  

At noon, the stock was off the 52-week high and trading with a cut of 0.5 per cent for the day at Rs 1,390.3 apiece on the bourse.

The drugs are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus, according to the company’s regulatory filing post-market hours on Thursday.

The product will be manufactured at Lupin’s Pithampur facility in Madhya Pradesh, according to the filing.

The Dapagliflozin and Saxagliptin tablets have estimated annual sales of $5 million in the US, the company said.

Lupin shares: Past performance 

Lupin shares have rewarded investors with a return of more than 87 per cent in a year, sharply outperforming a rise of about 20 per cent in the headline Nifty50 index.  

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