Cipla shares surged more than three percent on Monday as the US Food and Drug Administration (US FDA) has given final approval to the company and its subsidiary Cipla USA Inc, for Lanreotide Injection.

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"The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway," Cipla said in an exchange filing.

"This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs. The active ingredient, route of administration and strengths are the same as Somatuline Depot, from Ipsen Biopharmaceuticals Inc. According to IQVIA, Somatuline Depot had US sales of approximately $867M for the 12-month period ending October 2021," said Umang Vohra, MD and Global CEO, Cipla.

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Cipla getting US FDA approval for Lanreotide Depot injection is a positive surprise, said Nomura adding that this development is not factored in the brokerage's earnings estimate.

Nomura has maintained its 'buy' call on Cipla shares with a target price of Rs 1,051.

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At 10:11 am, shares of Cipla were 2.7 percent higher at Rs 883.10 on BSE. They were the best performers on the Nifty50 index. The scrip has gained after two days of consecutive fall.

Cipla shares have risen nearly 8 percent in 2021 so far whereas the 50-stock index has gained 19 percent during the same period.

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