- Natco Pharma approved to manufacture and market generic Semaglutide in India
- The launch of generic Semaglutide is planned for March by Natco Pharma
- Semaglutide treats type 2 diabetes as an adjunct to diet and exercise
Natco Pharma Ltd. has received government approval to manufacture and market generic Semaglutide injection in India. The company will launch the product in March, according to a statement released on Saturday.
Semaglutide, a prescription-only medicine, is used for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, gave its nod for the launch.
Hyderabad-based Natco Pharma develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products.
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is approved by the US Food and Drug Administration as three separate brand name medications: Ozempic, Wegovy, and Rybelsus. All three brands are available in India. It works by helping the pancreas release a fair amount of insulin when blood glucose levels are high. Insulin directs the muscle and fat cells to take in glucose, which is utilised for energy.
The Indian semaglutide market is expected to be highly competitive with many generics, where Natco will launch its own brand and out-license to two other companies, senior executives told analysts during the third quarter earnings concall.
Semaglutide is projected to be the primary driver for the domestic business, targeting over 20% growth, with 350-400 medical representatives allocated for promotion. In the US, no competitor has FDA approval for semaglutide within 30 months, and Natco Pharma holds sole First-To-File (FTF) exclusivity for significant strengths of both Ozempic and Wegovy, with Ozempic already settled, they said.
Shares of Natco Pharma settled 2.1% lower at Rs 822.10 on Friday, compared to a 1.25% fall in the benchmark BSE Sensex.
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