Cipla gets USFDA approval for generic Somatuline Injection

About the Approval

Cipla Limited, a leading pharmaceutical company, has secured final approval from the USFDA for its generic version of Somatuline Depot (lanreotide) Injection. This approval opens doors for Cipla to enter the lucrative US market for the treatment of Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs), estimated at approximately USD 898 million annually.

Cipla’s Lanreotide Injection is supplied as 120 mg/0.5 ml, 90 mg/0.3 ml, and 60 mg/0.2 ml in pre-filled syringes for single-dose administration, offering convenience for patients. Being an AP-rated therapeutic equivalent to Somatuline Depot, Cipla’s generic version provides a high-quality and potentially more affordable treatment option.

This approval marks a significant milestone for Cipla’s US expansion plans. The company aims to leverage its expertise in developing high-quality generic medications to address unmet needs in the US market. Patients suffering from Acromegaly and GEP-NETs may now have broader access to this critical treatment.

Share Price Movement

Shares of Cipla surged 0.92% or 13.30 points to Rs 1,454.15 as compared to the previous day’s closing of Rs 1,443.20. The share opened at Rs 1,451.10 and touched an intraday high and low of Rs 1,462.85 and 1,437.10 respectively. The share has a 52-week high of Rs 1,519 and a 52-week low of Rs 919.75. The company has a market capitalisation of Rs 1,17,653.59 crore.

About the Company

Cipla, a global pharmaceutical company, has been focusing on growth, complex generics, and expanding its portfolio in India, South Africa, North America, and key markets. With 47 manufacturing sites worldwide, Cipla produces over 50 dosage forms and 1,500 products using advanced technology. The company is ranked 3rd in pharma in India, 1st in South Africa, and 4th by prescription in the US for Gx inhalation products. Cipla’s focus on patient care has inspired its work for over eight decades. Their groundbreaking triple anti-retroviral therapy in HIV/AIDS is a paradigm-changing offering.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.