Amneal Launches Lanreotide Injection for Oncology Treatments
News related to:Amneal Pharmaceuticals, Inc · 2 min read
Amneal Pharmaceuticals, Inc., a diversified global biopharmaceutical leader, has announced the approval and immediate launch of its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product, which references SOMATULINE® Depot, marks an expansion of the company’s complex injectables portfolio and is expected to drive significant growth.
The approval and launch of lanreotide injection are part of Amneal’s broader strategy to enhance its presence in the oncology market. The product is indicated for the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. With an in-house production capacity, Amneal is well-positioned to meet the demands of the market and ensure broad access to this important medicine.
Srinivas Kone, Ph.D., Senior Vice President and Chief Scientific Officer of Amneal’s Affordable Medicines division, stated, “The approval and launch of lanreotide add another material growth driver to our Affordable Medicines business. Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities.”
Amneal was founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel. The company has built a diverse and growing portfolio of approximately 300 complex generic, specialty, and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States.
The approval of lanreotide injection comes with a Competitive Generic Therapy (CGT) designation from the U.S. Food and Drug Administration (FDA). This designation is intended to encourage the development of generic versions of complex injectable products, which are often challenging to produce.
According to IQVIA, U.S. annual sales for SOMATULINE® Depot for the 12 months ended July 2026 were $983 million. Amneal’s immediate commercial launch of the product is supported by its large-scale in-house manufacturing capacity, ensuring reliable supply and broad access to this important medicine.
Amneal’s Affordable Medicines segment includes retail generics, injectables, and biosimilars, while its Specialty segment provides branded treatments in neurology and endocrinology. The AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers.
The approval and launch of lanreotide injection are part of Amneal’s ongoing efforts to expand access to affordable and innovative medicines. The company continues to focus on delivering value to patients, providers, and shareholders through its diverse portfolio of products and services.