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Dr Reddy’s Gets Brazil Nod for Generic Semaglutide Injection

Dr Reddy's
Dr Reddy's plans to launch in Brazil with local drugmaker Aché.

On 5 November, Dr Reddy’s Laboratories Ltd won ANVISA approval in Brazil for its generic semaglutide injection for adults with type 2 diabetes.

The Hyderabad-based drugmaker disclosed the nod in a filing with the National Stock Exchange. Brazil’s health regulator granted the marketing authorisation.

The injection is for adults whose type 2 diabetes is not well controlled.

Doctors can prescribe it alone when metformin, a common diabetes tablet, does not suit a patient.

It can also go alongside other diabetes medicines. Patients get a pre-filled pen that holds several doses and inject it once a week.

It will come in two strengths: 2 mg/1.5 mL and 4 mg/3 mL.

Dr Reddy’s plans to launch in Brazil with local drugmaker Aché. No launch date has been shared. Brazil has a lot of people living with diabetes.

About 16.6 million adults have the condition, the sixth-highest number in the world, according to the IDF Diabetes Atlas 2025.

Semaglutide for diabetes brought in around USD 244.6 million in Brazil in the year to September 2026, going by IQVIA data.

MV Ramana, CEO of Global Generics at Dr Reddy’s, said the company wants to widen access to semaglutide where patient need is high.

He called Brazil an important part of that effort. Brazil already counts among the company’s major markets, along with the US, India, Russia and other CIS countries, China and Europe.

Dr Reddy’s, set up in 1984, works in areas such as diabetes care, heart health, cancer and pain management.

The approval follows a bumpy few months for the company’s semaglutide plans.

In April, ANVISA had turned down its first Brazilian application on technical grounds.

In July, Dr Reddy’s paused commercial supplies of the injection after a quality problem turned up in the active ingredient, and said market supplies would resume from November 2026.

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