Cipla Ltd.

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Cipla gets USFDA’s final nod for Lanreotide injection

Date: 22-05-2024

Cipla and its wholly owned subsidiary Cipla USA Inc have 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-toinject 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 around $898 million for the 12-month period ending March 2024. 

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.