Sun Pharma receives DCGI approval for generic version of semaglutide injection

Sun Pharmaceutical Industries announced that it has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of semaglutide injection. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for chronic weight management in adults as an adjunct to a reduced calorie diet and increased physical activity.

Sun Pharma will launch generic semaglutide injection under the brand name, Noveltreat, after the expiry of semaglutide patent in India. The product has received approval from the DCGI following a review of a Phase III clinical trial conducted in India. Noveltreat 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, with a maintenance dose of 2.4 mg once weekly. The product is administered via an easy-to-use prefilled pen, designed to support convenient and accurate dosing.

 

Obesity and diabetes have emerged as two of the most pressing health challenges confronting India and GLP-1 based therapies can play a meaningful role in addressing this growing burden. Noveltreat meets global quality standards and is supported by robust Indian clinical evidence on efficacy and safety for weight management. As India's largest pharmaceutical company with leadership in cardiometabolic therapies, we are committed to improving access to generic semaglutide across the country after the patent expiry, said Kirti Ganorkar, Managing Director, Sun Pharma.

GLP-1 receptor agonists like semaglutide are an important scientific advancement for overall metabolic health, not just weight. These treatments should be combined with appropriate lifestyle measures such as diet and physical activity. They should be taken under close medical supervision. We are seeing growing patient interest in this therapy, and improved accessibility will help address unmet needs, said Dr. Unnikrishnan A G, Chief Endocrinologist and CEO, Chellaram Diabetes Institute.

In December 2025, Sun Pharma received DCGI approval for manufacturing and marketing semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. It will be launched under the brand name Sematrinity, after the expiry of semaglutide patent in India.

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