Natco Pharma's Generic Semaglutide to Hit Indian Market in March

New Delhi: Natco Pharma Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market generic Semaglutide Injection in India, with the company planning to launch the product in March 2026, according to a regulatory filing submitted to the stock exchanges.

In an intimation made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company informed BSE Ltd. and the National Stock Exchange of India Ltd. about the receipt of approval from CDSCO for Semaglutide in India. The communication was addressed to the Corporate Relationship Department of BSE and the Listing Department of NSE, where the company is listed under Scrip Code 524816 on BSE and NATCOPHARM on NSE.

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus and is used as an adjunct to diet and exercise. With this approval, NATCO will be able to manufacture and commercialize the generic version of Semaglutide Injection in the domestic market beginning March 2026.

Headquartered in Hyderabad, NATCO Pharma Limited develops, manufactures, and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. The company describes itself as an R&D-oriented and science-driven organization and is a leading oncology player in the targeted therapies segment of the domestic market, with a focus on limited competition molecules in the United States.

NATCO operates nine manufacturing sites and two R&D facilities in India. Its manufacturing facilities are approved by several leading regulatory authorities, including the U.S. FDA, Brazil's ANVISA, Health Canada, and WHO, catering to more than 50 global markets, according to a press release issued by the company.