Dr. Reddy's Laboratories Announces Health Canada Approval for Generic Semaglutide Injection in Canada
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Dr. Reddy’s becomes the first company to receive marketing authorization for generic Semaglutide Injection in
Canada - The market authorization was granted to Dr. Reddy’s ahead of Health Canada’s review target date
As per
Health Canada’s approval demonstrates Dr. Reddy’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 Limited.
* Semaglutide Injection (semaglutide) is indicated for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic control, in combination with
- diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance
- metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
- metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control
- metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), when diet and exercise plus metformin or a sulfonylurea, in addition to an SGLT2i, do not achieve adequate glycemic control
- basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control
Semaglutide has not been studied in combination with prandial insulin (short acting). Semaglutide Injection is not a substitute for insulin. Semaglutide Injection should not be used in patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM) or for the treatment of diabetic ketoacidosis.
Please consult the product monograph for complete prescribing information, warnings and precautions, adverse reactions, and contraindications.
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1
https://www.canada.ca/en/public-health/services/diseases/diabetes.html
2 IQVIA MAT Q3 2025 DATA
View source version on businesswire.com: https://www.businesswire.com/news/home/20260429333344/en/
INVESTOR RELATIONS
AISHWARYA SITHARAM
AISHWARYASITHARAM@DRREDDYS.COM
MEDIA RELATIONS
PRIYA K
PRIYAK@DRREDDYS.COM
Source: Dr. Reddy’s