Key Development

Dr. Reddy's Laboratories Ltd. announced that Brazil's National Health Surveillance Agency (ANVISA) has granted marketing authorization for the company's generic semaglutide injection. The approval was received on November 5, 2026.

Product Details

The approved product is a generic semaglutide injection indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise. It can be used as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for diabetes treatment.

The product will be available as a pre-filled, multi-dose injectable pen in two specific presentations:

  • 2 mg/1.5 mL
  • 4 mg/3 mL

Dosing regimen is once-weekly.

Market Context

Brazil has 16.6 million adults aged 20–79 living with diabetes, ranking sixth globally in terms of diabetic population. The semaglutide market for diabetes in Brazil is estimated at approximately USD 244.6 million (source: IQVIA, MAT September 2026).

Strategic Partnership and Launch Plans

The company plans to launch semaglutide in Brazil in partnership with Aché, a local pharmaceutical company. This expansion represents part of Dr. Reddy's broader semaglutide strategy to increase access to this treatment option.

Management Commentary

MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy's Laboratories, stated: "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."

Company Background

Dr. Reddy's Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India, established in 1984. The company's major therapeutic areas of focus include gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.