Natco Pharma Receives CDSCO Approval for Generic Semaglutide in India

Natco Pharma has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market generic semaglutide injection in India. The company plans to launch the product in the Indian market in March 2026.

Semaglutide, a GLP-1 receptor agonist, is used to treat adults with inadequately controlled type 2 diabetes and is prescribed along with diet and exercise. The drug is also used in chronic weight management, supported by clinical outcomes in glycaemic control and weight reduction.

Eris Lifesciences has announced a partnership with Natco Pharma for the commercialisation of semaglutide in India, reinforcing its focus on expanding its presence in the diabetes and metabolic care segment. The collaboration brings together Eris's commercial and diabetes franchise presence with Natco's manufacturing and regulatory capabilities in formulations.

The addition of semaglutide is expected to strengthen Eris's portfolio in diabetes therapies and expand its role in metabolic treatments. Eris has established a presence in diabetology, supported by specialist reach and engagement with endocrinologists, diabetologists and physicians across India.

With a growing diabetic population in India and rising awareness around obesity management, GLP-1 therapies represent an opportunity within the metabolic segment. The product will focus on Type 2 diabetes management in India's metabolic care segment.

Earlier, Natco Pharma had approached the Delhi High Court seeking revocation of Danish drugmaker Novo Nordisk's patent on semaglutide. Separately, Dr Reddy's Laboratories had also moved the Delhi High Court last year under the Patents Act and under the Commercial Courts Act, seeking cancellation of Indian Patent No. IN 262697 granted to Novo Nordisk.

Shares of Natco Pharma rallied 12.5% to touch a day's high of Rs 932 on 16th February following the CDSCO approval announcement.