Natco Pharma Wins Approval to Manufacture Semaglutide in India

Hyderabad-based Natco Pharma has achieved a significant milestone with India’s drug regulator approving its application to manufacture and market semaglutide injections. This development positions Natco as a key player in the expanding market for GLP-1 receptor agonists, widely prescribed for type 2 diabetes and weight management.

The approval comes at a crucial time, as Novo Nordisk’s patent on semaglutide (marketed globally as Ozempic and Wegovy) is set to expire in March 2026. Indian firms are preparing to capitalize on the demand surge for affordable alternatives.

Key Highlights

• Regulatory Approval: Natco Pharma cleared to produce multidose prefilled pens of semaglutide.
• Market Entry: Joins Torrent Pharma (oral tablets) and MSN Laboratories (injectable vials) in the Indian generics race.
• Global Demand: GLP-1 drugs are witnessing unprecedented demand for diabetes control and sustained weight loss.
• Strategic Timing: Patent expiry of Novo Nordisk’s blockbuster drug opens doors for Indian manufacturers.
• Export Potential: Natco also received court clearance to export semaglutide to select international markets.

Context
This approval strengthens India’s pharmaceutical ecosystem, offering cost-effective alternatives to expensive global therapies. Analysts expect strong domestic uptake and export opportunities, making semaglutide a major growth driver for Natco Pharma in 2026.

Sources: The Indian Practitioner, Mint, Scanx, Hindustan Times, Reuters