The share price of pharma company Cipla jumped more than 2% intraday to Rs 883.90 after the US Food and Drug Administration approved its Lanreotide injection.

“Cipla and its subsidiary Cipla USA, Inc have received the final approval for its Lanreotide injection from the United States Food and Drug Administration (USFDA),” according to a release from the company.

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The FDA granted clearance based on a New Drug Application (NDA) filed under the 505(b)(2) filing procedure.

Lanreotide injection is approved for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to the company. It is available in single-dose prefilled syringes of 60 mg/0.2 ml, 90 mg/0.3 ml, and 120 mg/0.5 ml.

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“We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of ‘Caring for Life’. 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,” said Umang Vohra, MD and Global CEO, Cipla.

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The active ingredient’s mode of administration and strengths are identical to those of Ipsen Biopharmaceuticals Inc.’s Somatuline Depot. Somatuline Depot had revenues of roughly $867 million for the fiscal year ending October 2021, according to Iqvia.

Nomura, a foreign research group, has maintained a ‘buy’ call on the stock, with a target price of Rs 1,051 per share.

Lanreotide Depot Injection has been approved by the FDA under the 505b(2) process. 

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Lanreotide Depot injection is expected to be released soon, according to Nomura. “The approval is a pleasant surprise that has not been considered in our earnings forecast,”,” it added.

Cipla was trading at Rs 882.60 on the BSE at 10:40 a.m., up 22.75 points or 2.65%.