Dr Reddy's Gets Brazil Approval For Generic Ozempic Diabetes Drug

Indian pharmaceutical major Dr Reddy's Laboratories announced on Thursday that it has received regulatory approval in Brazil to market and sell a generic version of Novo Nordisk's widely used diabetes medicine Ozempic.

Brazil's National Health Surveillance Agency (ANVISA) cleared the company's semaglutide injection for adults with type 2 diabetes whose blood sugar levels remain inadequately controlled.

The medicine is intended for use alongside diet and exercise.

The approval marks an important development in Dr Reddy's international expansion plans, with generic semaglutide identified as a potential growth driver across several markets.

The Brazilian regulator had previously rejected the drug's application in April because it did not meet all regulatory requirements.

Following the latest approval, Dr Reddy's can market the once-weekly injectable treatment in pre-filled pens containing 2 mg and 4 mg of semaglutide.

Brazil represents a significant market for diabetes treatments.

According to figures cited by the company, approximately 16.6 million adults aged 20 to 79 are living with diabetes in the country.

Brazil ranks sixth globally in terms of the adult population affected by the disease.

Semaglutide is the active ingredient in Novo Nordisk's Ozempic, used for type 2 diabetes, and Wegovy, a medicine developed for weight management.

Dr Reddy's has identified generic versions of the compound as an important opportunity for future business growth.

The company is preparing to relaunch generic semaglutide in Canada during the current quarter after an earlier product recall.

Dr Reddy's had withdrawn certain batches from the Canadian market following the detection of an impurity in the active pharmaceutical ingredient.

The company has also outlined plans to introduce semaglutide products in additional Latin American and African markets over the coming months.

These proposed launches form part of its strategy to expand its presence in international pharmaceutical markets.

The Brazilian approval strengthens Dr Reddy's position in the growing market for semaglutide-based diabetes treatments, although future launches remain subject to applicable regulatory requirements.