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Generic semaglutide launched in Canada by Dr. Reddy’s (NYSE: RDY)

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6-K

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories Ltd. has launched its generic Semaglutide Injection in Canada after receiving a Notice of Compliance from Health Canada on April 28, 2026. Canada is the first G7 country to grant market authorization for this product.

The once-weekly injection is indicated for adults with type 2 diabetes mellitus, to improve blood sugar control alongside diet and exercise. It is supplied as a sterile solution in pre-filled pens at 2 mg/pen and 4 mg/pen strengths, each at 1.34 mg/ml, delivering 0.25 mg, 0.5 mg, or 1 mg doses per injection.

The company highlights its established presence and market access in Canada and describes GLP-1 therapies, including semaglutide, as a key focus area. This Canadian launch follows a recent semaglutide introduction in India under the Obeda® brand and supports Dr. Reddy’s broader strategy to expand access to advanced, affordable diabetes treatments across multiple markets.

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Insights

Dr. Reddy’s adds a key GLP-1 generic in Canada.

Dr. Reddy’s has entered the Canadian GLP-1 diabetes market with its generic Semaglutide Injection after receiving a Health Canada Notice of Compliance on April 28, 2026. Canada is the first G7 country to authorize this product, giving the company an early presence.

The injection is indicated for adults with type 2 diabetes and offered as once-weekly pre-filled pens in 2 mg/pen and 4 mg/pen strengths at 1.34 mg/ml. This aligns with growing demand for GLP-1 therapies in diabetology and potentially broadens Dr. Reddy’s chronic-care portfolio in a developed market.

Management notes an existing commercial footprint and strong market access capabilities in Canada, and links this launch to a recent semaglutide introduction in India under the Obeda® brand. Future disclosures in company filings may clarify sales traction, competitive dynamics, and any further geographic rollouts of GLP-1 products.

Health Canada NOC date April 28, 2026 Notice of Compliance for generic Semaglutide Injection
Canadian launch date May 15, 2026 Launch of generic Semaglutide Injection in Canada
Semaglutide concentration 1.34 mg/ml Sterile solution in pre-filled pens
Pen strength (lower) 2 mg/pen Delivers 0.25 mg or 0.5 mg doses once weekly
Pen strength (higher) 4 mg/pen Delivers 1 mg dose per injection once weekly
Notice of Compliance (NOC) regulatory
"following the Notice of Compliance (NOC) received from Health Canada"
A notice of compliance (NOC) is an official regulatory authorization that allows a drug or medical device to be sold in a market after it has met required safety, quality and efficacy standards. For investors, an NOC is like receiving a business license: it removes a major legal barrier to revenue, lowers development risk, and can trigger manufacturing, sales and partnership opportunities that materially affect a company’s future earnings potential.
Semaglutide Injection medical
"today announced the launch of its generic Semaglutide Injection in Canada"
GLP-1 therapies medical
"we remain committed to bringing advanced, high-quality, and affordable GLP-1 therapies closer to patients"
Drugs that mimic or boost the gut hormone GLP‑1, which helps control blood sugar and appetite by telling the body to release more insulin and feel full sooner; they are used to treat type 2 diabetes and obesity. Investors watch these therapies because they can drive large prescription sales, change healthcare spending and market share among drugmakers, and face regulatory, patent and competitive risks that directly affect company value.
type 2 diabetes mellitus medical
"for the once-weekly treatment of adults with type 2 diabetes mellitus, to improve glycemic control"
A chronic metabolic condition in which the body cannot use insulin effectively, causing persistently high blood sugar levels that damage organs and increase risk of heart disease, kidney failure and other complications; think of insulin as a key and cells as locks that stop responding, so sugar stays in the bloodstream instead of fueling tissues. Investors care because the large, growing patient population drives demand for drugs, devices, diagnostics and long‑term healthcare spending, influencing pharmaceutical pipelines, regulatory reviews, reimbursement, and insurer costs.
product monograph regulatory
"Please consult the product monograph for complete prescribing information, warnings and precautions"
 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

May, 2026

 

Commission File Number 1-15182

 

DR. REDDY’S LABORATORIES LIMITED

(Translation of registrant’s name into English)

 

8-2-337, Road No. 3, Banjara Hills

Hyderabad, Telangana 500 034, India

+91-40-49002900

 

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F  x                                   Form 40-F   ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ______

 

Note:  Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ______

 

Note:  Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes  ¨                                   No   x

 

If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.

 

 

 

EXHIBITS

 

Exhibit

Number

  

Description of Exhibits

 

 

 

99.1


Intimation dated May 15, 2026

 

2

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

DR. REDDY’S LABORATORIES LIMITED

(Registrant)

 

 

Date: May 15, 2026   

By:

/s/ K Randhir Singh

 

 

Name:

K Randhir Singh

 

 

Title:

Company Secretary

 

3

 

Exhibit 99.1

 


Dr. Reddy's Laboratories Ltd.

8-2-337, Road No. 3, Banjara Hills

Hyderabad – 500 034, Telangana, India

 

CIN: L85195TG1984PLC004507

 

Tel:       + 91 40 4900 2900

Fax:     + 91 40 4900 2999

Email: mail@drreddys.com

Web:   www.drreddys.com

 

May 15, 2026

 

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)

BSE Limited (Scrip Code: 500124)

New York Stock Exchange Inc. (Stock Code: RDY)

NSE IFSC Ltd. (Stock Code: DRREDDY)

 

Dear Sir/Madam,

 

Ref:

Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015

 

Please find enclosed a Press Release viz. Dr. Reddy's Laboratories Launches its Generic Semaglutide Injection in Canada.

 

This is for your information and records.

 

Thanking you,

 

Yours faithfully,

For Dr. Reddy’s Laboratories Limited

K Randhir Singh

Company Secretary, Compliance Officer & Head-CSR

 

 



 

 

CONTACT

DR. REDDY'S LABORATORIES LTD.

 

INVESTOR RELATIONS

MEDIA RELATIONS

8-2-337, Road No. 3, Banjara Hills,

 

AISHWARYA SITHARAM

PRIYA K

Hyderabad - 500034. Telangana, India.

 

AISHWARYASITHARAM@DRREDDYS.COM

PRIYAK@DRREDDYS.COM

 

Dr. Reddy's Laboratories Launches its Generic Semaglutide Injection in Canada

 

·

The launch follows Dr. Reddy’s receipt of the Notice of Compliance (NOC) from Health Canada on April 28th, 2026, marking the company’s readiness to serve Canadian patients

·

Dr. Reddy’s is the first company to receive Health Canada approval for generic Semaglutide Injection in Canada

·

Canada is the first G7 country to grant market authorization for generic Semaglutide Injection

 

HYDERABAD, INDIA & MISSISSAUGA, ONTARIO, May 15, 2026 - 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 the launch of its generic Semaglutide Injection in Canada. Dr. Reddy’s is among the first companies to introduce a generic Semaglutide Injection in the Canadian market, following the Notice of Compliance (NOC) received from Health Canada on April 28th, 2026. Canada is the first G7 country to grant market authorization for Semaglutide Injection. The launch demonstrates Dr. Reddy’s readiness to ensure patient access following approval.

 

In Canada, Dr. Reddy’s Semaglutide Injection* is indicated for the once-weekly treatment of adults with type 2 diabetes mellitus, to improve glycemic control in combination with diet and exercise. It is supplied as a sterile solution for subcutaneous injection in a pre-filled pen, available in 2 mg/pen and 4 mg/pen strengths, each delivering Semaglutide at a concentration of 1.34 mg/ml. The 2 mg/pen is designed to deliver 0.25 mg or 0.5 mg doses, while the 4 mg/pen delivers 1 mg doses per injection.

 

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “We are pleased to launch our generic Semaglutide Injection in Canada, within days of receiving Health Canada approval. The milestone highlights our readiness to serve the Canadian patients, supported by our deep expertise in complex drug and peptide development. With a well-established presence and strong market access capabilities in Canada, we remain committed to bringing advanced, high-quality, and affordable GLP-1 therapies closer to patients. The Canada launch builds on the momentum of our recent launch in India under the brand name Obeda®. As GLP-1 therapies continue to be a key focus area for us, we are actively working to expand access across multiple global 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.

 

For more information, log on to: www.drreddys.com.

 

 


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.


FAQ

What did Dr. Reddy’s Laboratories (RDY) announce in this Form 6-K?

Dr. Reddy’s announced the launch of its generic Semaglutide Injection in Canada. The product targets adults with type 2 diabetes and follows a Notice of Compliance from Health Canada on April 28, 2026, making Canada the first G7 country to authorize this therapy.

What is Dr. Reddy’s generic Semaglutide Injection used for in Canada?

The generic Semaglutide Injection is indicated for once-weekly treatment of adults with type 2 diabetes mellitus. It is used to improve glycemic control in combination with diet and exercise, but is not a substitute for insulin and is not approved for type 1 diabetes or diabetic ketoacidosis.

What strengths and doses does Dr. Reddy’s Semaglutide Injection offer?

Dr. Reddy’s Semaglutide Injection is supplied as a sterile solution at 1.34 mg/ml in pre-filled pens. The 2 mg/pen presentation delivers 0.25 mg or 0.5 mg doses, while the 4 mg/pen delivers 1 mg per injection, providing flexible dosing options for adult patients with type 2 diabetes.

Why is the Canadian launch of Semaglutide Injection important for Dr. Reddy’s (RDY)?

The Canadian launch positions Dr. Reddy’s among the first to introduce a generic Semaglutide Injection in a G7 country. It supports the company’s focus on GLP-1 therapies, leverages its existing Canadian market access, and builds on a recent semaglutide launch in India under the Obeda® brand.

What regulatory milestone did Dr. Reddy’s achieve for Semaglutide in Canada?

Dr. Reddy’s received a Notice of Compliance from Health Canada on April 28, 2026, for its generic Semaglutide Injection. This regulatory approval granted market authorization in Canada, enabling the company to launch one of the first generic GLP-1 semaglutide products in a G7 market.

Does Dr. Reddy’s Semaglutide Injection replace insulin therapy?

Dr. Reddy’s Semaglutide Injection does not replace insulin therapy. It is indicated for once-weekly treatment of adult type 2 diabetes patients, but is not a substitute for insulin, is not for type 1 diabetes, and has not been studied with short-acting prandial insulin.

Filing Exhibits & Attachments

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