Dr. Reddy’s wins Brazil approval for semaglutide
The planned Brazilian launch will use two weekly-dose pen presentations; the country’s semaglutide market for diabetes is estimated at approximately USD 244.6 million.
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Rhea-AI Filing Summary
Dr. Reddy’s Laboratories Ltd. (RDY) said Brazil’s National Health Surveillance Agency (ANVISA) granted marketing authorization for generic semaglutide injection for adults with insufficiently controlled type 2 diabetes mellitus. The authorized use is as an adjunct to diet and exercise, either alone when metformin is considered inappropriate because of intolerance or contraindications, or with other diabetes medicines.
The product is a pre-filled, multi-dose injectable pen in two presentations, 2 mg/1.5 mL and 4 mg/3 mL, for once-weekly dosing. Dr. Reddy’s plans to launch it in Brazil with Aché. Brazil has 16.6 million adults aged 20–79 living with diabetes and ranks sixth globally by number of adults with diabetes; the Brazilian semaglutide market for diabetes is estimated at approximately USD 244.6 million.
Key Figures
Key Terms
marketing authorization regulatory
monotherapy medical
contraindications medical
pre-filled, multi-dose injectable pen medical
FAQ
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What is RDY’s generic semaglutide injection authorized to treat in Brazil?
How is RDY’s generic semaglutide supplied and dosed in Brazil?
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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
November, 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 November 5, 2026 |
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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: November 5, 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 CIN: L85195TG1984PLC004507 Tel: + 91 40 4900 2900 Fax: + 91 40 4900 2999 Email: mail@drreddys.com Web: www.drreddys.com |
November 5, 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 receives marketing authorization for generic semaglutide injection in Brazil.”
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
DR. REDDY'S LABORATORIES LTD. |
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8-2-337, Road No. 3, Banjara Hills, |
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Hyderabad - 500034. Telangana, India. | CONTACT | |
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CIN: L85195TG1984PLC004507 | INVESTOR RELATIONS | MEDIA RELATIONS |
Tel: + 91 40 4900 2900 |
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Fax: + 91 40 4900 2999 | AISHWARYA SITHARAM | SANTOSH VYAS |
Email: mail@drreddys.com | AISHWARYASITHARAM@DRREDDYS.COM | SANTOSHVYAS@DRREDDYS.COM |
Web: www.drreddys.com |
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Dr. Reddy’s receives marketing authorization for generic semaglutide injection in Brazil
· | ANVISA grants marketing authorization for generic semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise |
· | The approval expands Dr. Reddy’s semaglutide presence to Brazil, one of the key markets in Latin America |
Hyderabad, India; November 5, 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”, today announced that Brazil’s National Health Surveillance Agency (ANVISA) has granted marketing authorization for generic semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes. The product will be available as a pre-filled, multi-dose injectable pen in two presentations, 2 mg/1.5 mL and 4 mg/3 mL, for once-weekly dosing.
Brazil has 16.6 million adults aged 20–79 living with diabetes and ranks sixth globally in terms of the number of adults living with diabetes.1 Reflecting the significant treatment need in the country, the semaglutide market for diabetes is estimated at approximately USD 244.6 million.2
Commenting on the approval, MV Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said, “Our focus with semaglutide is to expand access to this treatment option across markets where the patient need is significant. Brazil, with its substantial burden of diabetes, is an important part of that journey. This approval builds on our broader semaglutide strategy and brings us another step closer to making semaglutide available to more patients. We plan to launch semaglutide in Brazil with Aché.”
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, 2026. The company assumes no obligation to update any information contained herein.
1 | Source: IDF Diabetes Atlas 2025, 11th edition. |
2 | Source: IQVIA, MAT September 2026. |