Full Press Release Details
ANVISA grants marketing authorization for generic semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise
The approval expands Dr. Reddy’s semaglutide presence to Brazil, one of the key markets in Latin America
Hyderabad, India; November 5, 2026: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY), along with its subsidiaries together referred to as “Dr. Reddy’s”, today announced that Brazil’s National Health Surveillance Agency (ANVISA) has granted marketing authorization for generic semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes. The product will be available as a pre-filled, multi-dose injectable pen in two presentations, 2 mg/1.5 mL and 4 mg/3 mL, for once-weekly dosing.
Brazil has 16.6 million adults aged 20–79 living with diabetes and ranks sixth globally in terms of the number of adults living with diabetes.1 Reflecting the significant treatment need in the country, the semaglutide market for diabetes is estimated at approximately USD 244.6 million.2
Commenting on the approval, MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said, “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.”
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
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1 | Source: IDF Diabetes Atlas 2025, 11th edition.
2 | Source: IQVIA, MAT September 2026.