Sun Pharma Gains DCGI Approval for Generic Semaglutide in India

Sun Pharmaceutical Industries Limited has announced the receipt of approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of semaglutide injection in India. The product, named Noveltreat, is indicated for chronic weight management in adults. It will be launched after the expiration of the semaglutide patent in India. This approval follows a Phase III clinical trial conducted in India, which evaluated the efficacy and safety of the product.

The financial terms related to the launch of Noveltreat have not been disclosed in the filing. However, the approval allows Sun Pharma to enter the market for chronic weight management therapies in India. The product will be available in five dose strengths: 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, and 2.4 mg/0.75 mL. The maintenance dose is set at 2.4 mg once weekly. The product is designed for administration via a prefilled pen, which supports convenient and accurate dosing.

Operationally, Sun Pharma will manufacture Noveltreat at its facilities in India. The product’s design includes a prefilled pen to facilitate ease of use and ensure precise dosing. The company has emphasized that the product meets global quality standards and is supported by robust clinical evidence from trials conducted in India. This aligns with Sun Pharma’s strategy to enhance its portfolio in the cardiometabolic therapy segment.

The timeline for the launch of Noveltreat is contingent upon the expiration of the semaglutide patent in India. Sun Pharma has not specified an exact launch date but has indicated readiness to introduce the product to the market following patent expiry. The company has completed the necessary clinical trials and regulatory reviews, positioning it to proceed with commercialization once the patent barrier is removed.

Sun Pharma, as the sole entity involved in this development, will handle the manufacturing, marketing, and distribution of Noveltreat. The company has not disclosed any partnerships or collaborations related to this product in the filing. Sun Pharma’s role encompasses all aspects of bringing the generic semaglutide injection to market in India.

In the context of the Indian market, the approval of Noveltreat is significant given the rising prevalence of obesity and diabetes. According to the National Family Health Survey-5, nearly one in four Indians aged 15-49 is overweight or obese. The introduction of a generic semaglutide injection could address the growing demand for effective weight management therapies. Additionally, the product’s approval for type 2 diabetes management under the brand name Sematrinity further expands its therapeutic applications.

Sun Pharmaceutical Industries Limited is a leading specialty generics company with a presence in specialty, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a prominent player in the U.S. and global emerging markets. Sun Pharma’s operations span over 100 countries, supported by a multicultural workforce from over 50 nations. The company focuses on delivering high-quality medicines across various therapeutic areas.