Cipla Ltd. has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United States Food and Drug Administration (USFDA).

Cipla’s Lanreotide Injection is an AP-rated therapeutic equivalent generic version of Somatuline Depot (lanreotide) Injection. Lanreotide Injection is supplied as 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL single-dose, pre-filled, ready-to-inject syringe. Cipla’s Lanreotide injection is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).

According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately USD 898 million for the 12 months ending March 2024.

Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Its strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments are well-known.

The company has 47 manufacturing sites around the world that produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India, 1st in the pharma prescription market in South Africa and 4th largest by prescription in the US Gx inhalation products. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work.