Sun Pharmaceutical Industries Limited has filed an intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, regarding regulatory approval received for a new product.
The company announced it has received approval from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of semaglutide injection in South Africa. The approval is for the treatment of adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
Product details include:
- Pre-filled, multi-dose injectable pen format
- Two available strengths: 2 mg/1.5 mL and 4 mg/3 mL
- Flexible, once-weekly dosing regimen
Sun Pharma plans to launch the product in the South African market "in the coming days." This represents the second market approval for Sun Pharma's generic semaglutide after India.
According to Aalok Shanghvi, Chief Operating Officer of Sun Pharma, this approval "reflects our ability to develop complex generic medicines that meet the stringent quality standards across different markets." The company stated it remains committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals.
The disclosure highlights the growing burden of type 2 diabetes in South Africa, driven by rapid urbanization and changing lifestyles, which places significant pressure on patients and healthcare services.
Contacts
Investors: Dr. Abhishek Sharma, Tel: +91 22 4324 4324 (Xtn 2929), Direct: +91 22 4324 2929, Mobile: +91 98196 86016, Email: abhi.sharma@sunpharma.com
Media: Gaurav Chugh, Tel: +91 22 4324 4324 (Xtn 5373), Direct: +91 22 4324 5373, Mobile: +91 98104 71414, Email: gaurav.chugh@sunpharma.com