Product Approval Details

Sun Pharmaceutical Industries Limited has received approval from the Brazilian Health Regulatory Agency (ANVISA) to manufacture and market semaglutide injection in Brazil. The approval is for the treatment of adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Product Specifications

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

  • 2 mg/1.5 mL
  • 4 mg/3 mL

The product allows for flexible, once-weekly dosing.

Launch Plans

Sun Pharma plans to launch the product in Brazil in the next few days through a partnership with Hypera Pharma, described as a leading pharmaceutical company in Brazil.

Market Context

The semaglutide injectable market in Brazil is approximately USD 413 million, according to IQVIA MAT data as of June 2026.

Management Commentary

Aalok Shanghvi, Chief Operating Officer, Sun Pharma: "The approval of semaglutide in Brazil expands access to an evidence-based treatment option for people living with inadequately controlled type 2 diabetes. It reflects the strength of our development and manufacturing capabilities and our commitment to delivering high-quality medicines across global markets."

Digvijay Singh, Regional Head, Brazil & LATAM: "This approval marks an important step in strengthening our diabetes portfolio in Brazil. We look forward to working closely with our partner to make this treatment option available to patients and support better diabetes care across the country."

Company Background

Sun Pharma is a leading global pharmaceutical company with presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the US and Global Emerging Markets. The company's Innovative Medicines portfolio accounts for about 22% of company sales and spans dermatology, ophthalmology, and oncodermatology. Sun Pharma operates in over 100 countries with manufacturing facilities across five continents.

Contacts

Investors: Dr. Abhishek Sharma, Tel: +91 22 4324, Ext 2929, Direct: +91 22 4324 2929, Mobile: +91 98196 86016, Email: abhi.sharma@sunpharma.com

Media: Gaurav Chugh, Tel: +91 22 4324 4324, Ext 5373, Direct: +91 22 4324 5373, Mobile: +91 98104 71414, Email: gaurav.chugh@sunpharma.com