Cipla receives final approval for the generic version of Somatuline® Depot (lanreotide) Injection 120 mg/ 0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL

Mumbai, India & Warren, New Jersey, USA, May 22, 2024: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as “Cipla”), today announced that it 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 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 $898M for the 12-month period ending March 2024.