Dr. Reddy’s (NYSE: RDY) first with generic Semaglutide Injection approval in Canada
Rhea-AI Filing Summary
Dr. Reddy’s Laboratories reports that it has received a Notice of Compliance from Health Canada for its generic Semaglutide Injection, authorizing commercialization, sale and distribution in Canada. The approval covers 2 mg/pen and 4 mg/pen strengths at 1.34 mg/mL and does not have a fixed expiry date. Dr. Reddy’s states it is the first company to obtain market authorization for generic Semaglutide Injection in Canada and has launch preparations underway. The company highlights that GLP‑1 receptor agonist therapies such as Semaglutide are supported by extensive clinical evidence for improving glycemic control in adults with type 2 diabetes and notes that Canada is recognized as the world’s second‑largest market for Semaglutide.
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Insights
Health Canada’s Semaglutide approval opens a new generic GLP‑1 market for Dr. Reddy’s in Canada.
Dr. Reddy’s has received a Health Canada Notice of Compliance for its generic Semaglutide Injection, covering 2 mg/pen and 4 mg/pen strengths. This gives formal authorization to commercialize, sell and distribute the product in Canada.
The company states it is the first to gain generic Semaglutide Injection market authorization in a country it describes as the world’s second‑largest Semaglutide market. This positions Dr. Reddy’s to participate in a sizable GLP‑1 diabetes segment once launch preparations conclude.
The release notes in‑house API production, peptide expertise and a manufacturing partner, suggesting an integrated supply setup for this complex generic. Future disclosures in company filings may provide more detail on launch timing, pricing and contribution to the diabetes portfolio in Canada and other regulated markets.
Key Figures
Key Terms
Notice of Compliance (NOC) regulatory
Abbreviated New Drug Submission (ANDS) regulatory
GLP-1 receptor agonist medical
product monograph regulatory
type 2 diabetes mellitus medical
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
April, 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 |
| Description of Exhibits |
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99.1 | Intimation dated April 29,2026 |
| 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) | |||
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Date: April 29,2026 | By: | /s/ K Randhir Singh | ||
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| Name: |
| K Randhir Singh |
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| 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 |
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| CIN: L85195TG1984PLC004507 |
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| Tel: + 91 40 4900 2900 Fax: + 91 40 4900 2999 Email: mail@drreddys.com Web: www.drreddys.com |
April 29, 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 (“SEBI Listing Regulations”) |
This is to inform that Dr. Reddy’s Laboratories Limited (“Dr. Reddy’s”) has on April 29, 2026, 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. The relevant details as required under Regulation 30 of the SEBI Listing Regulations read with the SEBI Circular No. HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated January 30, 2026, are as hereunder:
1 | Name of the regulatory or licensing authority. | Pharmaceutical Drugs Directorate, Canada, (Health Canada) |
2 | Brief details of the approval/license obtained. | Notice of Compliance (NOC) granted for Semaglutide Injection |
3 | Impact/relevance of such approval/license to the listed entity. | The issuance of the NOC authorizes the commercialization, sale, and distribution of Semaglutide Injection in Canada |
4 | Period for which such approval/license is valid. | The approval does not have a fixed expiry date |
A press release being issued in relation to the above matter is enclosed for reference.
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
Encl: As above
| CONTACT | |
DR. REDDY'S LABORATORIES LTD. | INVESTOR RELATIONS | MEDIA RELATIONS |
8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | AISHWARYA SITHARAM | PRIYA K |
AISHWARYASITHARAM@DRREDDYS.COM | PRIYAK@DRREDDYS.COM | |
Dr. Reddy's Laboratories Announces Health Canada Approval for Generic
Semaglutide Injection in Canada
• | 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, April 29, 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 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.
1 https://www.canada.ca/en/public-health/services/diseases/diabetes.html
2 IQVIA MAT Q3 2025 DATA
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.
For more information, log on to: www.drreddys.com.
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