Cipla gets final approval for generic Somatuline® Depot (Lanreotide) Injection

Cipla Limited, alongside its subsidiary Cipla USA Inc., received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection. This product, an AP-rated therapeutic equivalent to Somatuline® Depot (Lanreotide), will be available in three dosages: 120 mg/0.5 mL, 90 mg/0.3 mL, and 60 mg/0.2 mL.

Lanreotide Injection by Cipla is designed for patients suffering from Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). The product comes as a single-dose, pre-filled syringe, ready for injection. The original brand, Somatuline® Depot, recorded U.S. sales amounting to approximately $898 million for the one-year period ending March 2024, according to IQVIA data.

Founded in 1935, Cipla has grown into a global pharmaceutical entity, emphasizing agile and sustainable growth, particularly in the production of complex generics. The company has a significant presence in India, South Africa, North America, and other regulated and emerging markets. Cipla is notably strong in several therapeutic areas, including respiratory, anti-retroviral, urology, cardiology, anti-infective, and central nervous system segments.

Cipla operates 47 manufacturing sites globally, producing over 1,500 products in more than 50 dosage forms. This extensive product portfolio caters to over 80 markets worldwide. The company holds the position of the third-largest pharmaceutical company in India and is the leading player in the pharma prescription market in South Africa. In the U.S., Cipla ranks as the fourth-largest by prescription in the generic inhalation product segment.

The company has a long history of contributing to public health. One of its significant accomplishments was the introduction of a triple anti-retroviral therapy for HIV/AIDS in Africa in 2001, priced at less than a dollar a day. This initiative has been widely recognized for making HIV treatment more accessible and affordable, thereby contributing significantly to the global fight against HIV/AIDS.

Cipla's commitment to healthcare goes beyond its product offerings. With a humanitarian approach, the company fosters deep-rooted community connections and aims to make healthcare accessible to all, living up to its mission of 'Caring for Life'. This approach has made Cipla a preferred partner for global health organizations, fellow pharmaceutical companies, and various stakeholders.

Cipla’s recent USFDA approval for Lanreotide Injection marks another milestone in its efforts to provide effective and accessible healthcare solutions. With this new product, Cipla aims to serve the needs of patients with Acromegaly and GEP-NETs, reinforcing its position as a key player in the global pharmaceutical industry.