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Cipla secures USFDA approval for pancreatic disease injection, shares surge

MUMBAI: Mumbai-headquartered pharma major, Cipla's US arm has secured final approval from the United States Food and Drug Administration (USFDA) for its Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, and 60 mg/0.2 mL.

The injection, pre-filled and ready to use, is an AP-rated therapeutic generic version of Somatuline Depot injection used in the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEPNETs), the company informed in its stock filing.

It further added, explaining the importance of the approval in the US, "The approval for the generic version of Lanreotide Acetate is in line with Cipla's growth strategy in the complex product segment and will strengthen Cipla's position in the US market. "

The approval for the drug remains valid as long as the product complies with USFDA regulations and standards, the company informed.

Following the information, Cipla's stock price surged over 2.07 per cent from Tuesday's closing price of Rs 1442.3, marking a percentage change of 2.02 per cent at the time of filing this report.

According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.

Last week, the Indian pharmaceutical giant reported its fourth-quarter earnings, in which a consolidated net profit of Rs 939 crore was reported, a whopping 79 per cent more than the previous year's Rs 525.6 crore. The company defied the street projection of Rs 923.5 crore.

Cipla's operating profit or EBITDA, increased 12 per cent YoY to Rs 1316 crore, while margins expanded by 80 basis points.

Established in 1935, Cipla is a global pharmaceutical company well known for its strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. Its 47 manufacturing sites around the world produce 50 plus dosage forms and 1,500 plus products to cater to 80-plus markets. Cipla is ranked the third largest in pharma in India.


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