A notice of compliance is an official letter from a health regulator saying a drug or medical device has met the agency’s requirements and can be marketed. For investors, it’s like a product earning its commercial license: it opens the door to sales and revenue while reducing the regulatory risk that could have blocked the product’s launch.
glp‑1 receptor agonistmedical
A GLP‑1 receptor agonist is a type of medication that mimics a natural gut hormone to help control blood sugar and reduce appetite; think of it as a key that fits a specific lock to boost insulin release when needed and slow digestion. Investors watch these drugs because they can treat large markets like diabetes and obesity, drive significant sales or pipeline value, and carry regulatory, safety and reimbursement risks that affect company valuations.
hbA1cmedical
A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.
sodium-glucose cotransporter 2 inhibitormedical
A sodium-glucose cotransporter 2 inhibitor is a class of prescription medicines that tells the kidneys to stop reabsorbing sugar, so excess glucose is removed from the body in the urine — think of it as opening a valve in a filter so sugar flows out. Investors care because these drugs can alter sales and profit forecasts through widespread use, label expansions into heart and kidney benefits, competitive market share, patent status, and regulatory or safety developments that affect a drug's commercial outlook.
sglt2imedical
A class of medicines that lower blood sugar by blocking the kidney’s pathway that normally pulls sugar back into the body—think of it as closing a gate so more sugar is flushed out in urine. Beyond diabetes, these drugs have shown benefits for heart and kidney health, so they can expand a maker’s sales and change treatment standards. Investors watch their sales growth, patent status, regulatory approvals, and competition because those factors strongly affect drugmakers’ revenues and valuations.
basal insulinmedical
A long-acting form of insulin that people with diabetes use to keep blood sugar steady throughout the day and night, acting like a slow-release background dose rather than a quick corrective shot after meals. Investors care because basal insulin represents a large, recurring-market product category with predictable demand, pricing and patent competition; changes in treatment guidelines, new delivery methods or patent expiries can materially affect a company’s sales and future growth.
diabetic ketoacidosismedical
Diabetic ketoacidosis is a serious, sudden complication of uncontrolled diabetes where the body, unable to use sugar for energy, breaks down fat and produces acidic chemicals called ketones, causing very high blood sugar, dehydration and a dangerous change in blood chemistry. It matters to investors because DKA drives hospital admissions, affects demand for diabetes medicines, devices and emergency care, and can influence clinical trial results, regulatory decisions and a company’s costs or liability exposure — like a sudden engine failure forcing expensive repairs.
type 1 diabetes mellitusmedical
An autoimmune condition in which the body’s immune system destroys insulin-producing cells in the pancreas, leaving the body unable to regulate blood sugar; think of insulin as a key that opens cells to allow sugar in, and type 1 diabetes removes that key. It matters to investors because it creates a lifelong need for treatments, devices and care, making therapies, insulin delivery technology and related regulatory approvals important drivers of long-term revenue and clinical risk in healthcare investments.
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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
HYDERABAD, India & MISSISSAUGA, Ontario--(BUSINESS WIRE)--
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), a global pharmaceutical company, today announced that it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection. Dr. Reddy’s becomes the first company to receive the market authorization for generic Semaglutide Injection* in Canada, ahead of Health Canada’s review target date. The market authorization covers the 2 mg / pen (1.34 mg / mL) and 4 mg / pen (1.34 mg / mL). With launch preparations underway, Dr. Reddy’s is well-positioned to bring this important treatment option available to Canadian patients.
As per Public Health Agency of Canada, around 3.9 million people (9.7% of the population) in Canada over a year old live with diagnosed diabetes. In addition, over 6% of adults in Canada live with prediabetes, which gives them a higher chance of developing type 2 diabetes. The number of people living with diabetes is expected to continue to increase as Canada's population ages and grows 1. GLP‑1 receptor agonist therapies, including Semaglutide, are supported by a substantial global clinical evidence base demonstrating improvements in glycemic control, as measured by HbA1c, in adults with type 2 diabetes when used as part of a comprehensive diabetes management strategy. Canada is recognized as the world's second-largest market for Semaglutide2.
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.
Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “The approval of our generic Semaglutide Injection by Health Canada represents a significant milestone in our GLP-1 journey and underscores our expertise in complex product development, peptide science, and our ability to meet stringent global regulatory standards. Canada remains a priority market for us. As the first company to receive market authorization for generic Semaglutide Injection in Canada, we remain dedicated to expanding access to innovative, high‑quality, affordable GLP‑1 treatments for patients with diabetes in the country. Additionally, with our in-house development capabilities, we are committed to ensuring a reliable and consistent supply of this important therapy for Canadian patients. This approval further fortifies our long-standing presence in Canada and enhances our diabetes management portfolio for regulated markets.”
* 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.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait,’ we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.
