Hyderabad-based Natco Pharma has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market generic semaglutide injection in India. According to reports from CNBC TV18 and Business Standard, the company announced this development through an exchange filing, marking a significant regulatory milestone for the pharmaceutical manufacturer. As reported by Parthika Patel from The Economic Times, this approval provides the company with the necessary regulatory clearance to proceed with commercial manufacturing and marketing of the generic version of the diabetes medication.
The weight-loss drug market in India is experiencing a significant transformation as generic versions of semaglutide become available in March 2026 following Novo Nordisk's patent expiry. As reported by multiple sources, Natco Pharma, Zydus Group, Sun Pharma (brand Noveltreat), and Dr. Reddy's Laboratories are all preparing for Day 1 launches, with generics expected to be priced at 50-60% below the innovator brand. This development comes as Eli Lilly's Mounjaro has already become India's top-selling drug by value, adding ₹105 crore in December 2025 to reach a total of ₹600 crore since launch in March 2025.
The company has planned to launch the generic semaglutide injection in the Indian market in March 2026. As reported by CNBC TV18 and Business Standard, this timeline provides clarity on the commercial rollout strategy for the diabetes treatment medication in the domestic market, positioning Natco Pharma to capitalize on the anticipated price war in the weight-loss drug segment. The approval from CDSCO now enables the company to move forward with its commercial manufacturing and marketing plans for the generic version of the medication.
Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, serving as an adjunct to diet and exercise. According to Business Standard, this therapeutic positioning addresses a significant medical need in the diabetes treatment sector, with the drug also gaining popularity in obesity treatments as India is projected to have the world's second-largest obese population by 2050.
Natco Pharma had earlier filed a suit before the Delhi High Court seeking revocation of Danish drugmaker Novo Nordisk's patent over semaglutide. As reported by CNBC TV18, this legal action represents part of the broader pharmaceutical industry's efforts to challenge patent protections on key diabetes medications, with the patent expiry creating opportunities for generic manufacturers to enter the market.
Shares of Natco Pharma Ltd. settled 2.13% lower on Friday at ₹822. According to CNBC TV18, the stock is down 8% on a year-to-date basis, reflecting broader market conditions and investor sentiment toward the pharmaceutical sector amid the upcoming generic competition in the weight-loss drug market. However, recent financial analysis suggests Natco Pharma appears financially stable compared to its competitors, with the company maintaining a market cap of ₹15,486 crores and showing strong fundamentals in its diversified pharmaceutical operations. The company also announced Q3 2026 earnings with revenue jumping 36.3% YoY to ₹647.3 crore and net profit up 14.3%, demonstrating robust financial performance.
