Sun Pharma secures DGCI approval for manufacturing and marketing of generic semaglutide injection in India

Shares of Sun Pharmaceuticals will be in focus on Friday’s trading session after the company secured DGCI approval to manufacture and market a weight management injection in India.

The exchange filing read, “Sun Pharma 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 the 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.

Commenting on the significant development, Kirti Ganorkar, Managing Director, Sun Pharma, said, “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”

GLP-1 agonists are a class of medications utilised to treat type 2 diabetes mellitus (T2DM) and obesity. These therapies, including semaglutide, are considered as highly effective treatment options for people with T2DM and obesity, while reducing cardiovascular and renal morbidity and mortality.