Dr. Reddy's Laboratories has received a Notice of Compliance (i.e. an approval) from the Pharmaceutical Drugs Directorate, Canada (Health Canada) regarding its Abbreviated New Drug Submission (ANDS) of Semaglutide Injection (semaglutide). The company becomes the first company to receive the market authorization for generic Semaglutide Injection in Canada, ahead of Health Canada’s review target date. Semaglutide is indicated for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic control.

The market authorization covers the 2 mg / pen (1.34 mg / mL) and 4 mg / pen (1.34 mg / mL). With launch preparations underway, the company’s is well-positioned to bring this important treatment option available to Canadian patients. Health Canada’s approval demonstrates the company’s expertise in complex generics and peptide-based therapeutics, supported by in-house API as well as formulation development capabilities. The API is entirely produced in-house, with finished product manufacturing currently carried out by the company’s manufacturing partner, OneSource Specialty Pharma.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.