New Delhi: Indian pharmaceutical company Dr. Reddy’s Laboratories has received regulatory approval in Brazil to market and sell a generic version of Novo Nordisk’s diabetes drug Ozempic.
Brazil’s National Health Surveillance Agency (ANVISA) has authorised the generic semaglutide drug for adults with type 2 diabetes whose condition is not adequately controlled. The treatment is intended to be used alongside diet and exercise.
According to Dr. Reddy’s, Brazil has 16.6 million adults aged between 20 and 79 living with diabetes, making it the sixth-largest country globally by the number of adults affected by the condition.
MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, stated that, “Our focus with semaglutide is to expand access to this treatment option across markets where the patient need is significant.”
“Brazil, with its substantial burden of diabetes, is an important part of that journey. This approval builds on our broader semaglutide strategy and brings us another step closer to making semaglutide available to more patients. We plan to launch semaglutide in Brazil with Aché,” the CEO noted.
The once-weekly injectable medication will be available in pre-filled injector pens containing 2 mg and 4 mg doses. The approval follows an earlier setback in April, when ANVISA rejected the company’s application because it did not meet all regulatory requirements.
Dr. Reddy’s has identified generic semaglutide, the active ingredient in Ozempic and Novo Nordisk’s weight-loss drug Wegovy, as a major growth opportunity in India and several international markets.
The company had earlier recalled batches of its generic semaglutide product in Canada after detecting an impurity in the active ingredient. It plans to relaunch the medicine in Canada during the fourth quarter of 2026.
ALSO READ | Novo Nordisk raises outlook as Wegovy pill drives growth
