Sun Pharma shares in focus on DCGI approval for generic Semaglutide injection

Sun Pharmaceutical Industries Ltd on Friday said it has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of Semaglutide injection for chronic weight management in adults.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for weight management as an adjunct to a reduced-calorie diet and increased physical activity. Sun Pharma said it will launch the product under the brand name Noveltreat after the expiry of the Semaglutide patent in India.

The approval follows 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 recommended maintenance dose of 2.4 mg administered once weekly. The injection will be offered through a prefilled pen designed for ease of use 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 at Sun Pharma.

Commenting on the therapy, Dr Unnikrishnan A G, Chief Endocrinologist and CEO, Chellaram Diabetes Institute, said, "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."

Separately, in December 2025, Sun Pharma had received DCGI approval to manufacture and market Semaglutide injection for adults with insufficiently controlled type 2 diabetes mellitus. That product will be launched under the brand name Sematrinity after patent expiry.

GLP-1 receptor agonists are widely used in the treatment of type 2 diabetes and obesity. According to the National Family Health Survey-5, nearly one in four Indians aged 15–49 is overweight or obese.