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Semaglutide approval still pending for Dr. Reddy’s (NYSE: RDY) in Canada

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories filed a Form 6-K explaining the status of its Semaglutide Injection in Canada after a media report. The company confirms the news headline is accurate: it is still awaiting Health Canada’s approval, referred to as a Notice of Compliance, for this product.

Dr. Reddy’s notes that, as part of the ongoing regulatory review, it received Drug Identification Numbers (DINs) for Semaglutide Injection from Health Canada on April 22, 2026. The company states it remains engaged with the regulator and intends to bring the product to the Canadian market once approval is granted. It also clarifies that, at this stage, there is no material event or information requiring disclosure under Regulation 30 of the SEBI Listing Regulations.

Positive

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DINs received date April 22, 2026 Health Canada Drug Identification Numbers for Semaglutide Injection
News item date April 23, 2026 Media report about Semaglutide approval status
Company intimation date April 24, 2026 Letter clarifying Semaglutide regulatory status
Regulation 30(11) regulatory
"This is in reference to Regulation 30(11) of the SEBI (Listing Obligations..."
SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 regulatory
"Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015..."
Notice of Compliance regulatory
"has not yet received approval (‘Notice of Compliance’) for its Semaglutide Injection from Health Canada"
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.
Drug Identification Numbers (DINs) regulatory
"received the ‘Drug Identification Numbers (DINs)’ for Semaglutide Injection from Health Canada"
Semaglutide Injection medical
"approval (‘Notice of Compliance’) for its Semaglutide Injection from Health Canada"
 


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
Number

  

Description of Exhibits

 

 

 

99.1


Intimation dated April 24, 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: April 24, 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

 

April 24, 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,

 

Sub:

Disclosure pursuant to Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – clarification on news item appearing in "https://www.cnbctv18.com/"dated April 23, 2026 captioned "Dr. Reddy's Laboratories still awaiting approval for a major near-term trigger, sources say"

 

This is in reference to Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (“SEBI Listing Regulations”) regarding  a news item appearing in "https://www.cnbctv18.com/" dated April 23, 2026 captioned "Dr. Reddy's Laboratories still awaiting approval for a major near-term trigger, sources say”.

 

In this connection, we wish to inform that the above captioned news item headline is correct, as the Company has not yet received approval (‘Notice of Compliance’) for its Semaglutide Injection from Health Canada. We further wish to inform that as part of the regulatory review process, the Company has received the ‘Drug Identification Numbers (DINs)’ for Semaglutide Injection from Health Canada on April 22, 2026. We continue to engage constructively with the regulatory authority and remain committed to bringing the product to the Canadian market upon approval. 

 

In compliance with Regulation 30 of the SEBI Listing Regulations, the Company makes prompt disclosures, as and when any event or information is considered material or warrants such disclosure under the said Regulations. We would also like to inform you that at this stage there is no material event/ information that requires disclosure under Regulation 30 of the SEBI Listing Regulations. 

 

This is for your information and records.

 

Thanking you,

 

Yours faithfully,

For Dr. Reddy’s Laboratories Limited


K Randhir Singh

Company Secretary, Compliance Officer and Head-CSR

 

 

FAQ

What did Dr. Reddy’s Laboratories (RDY) disclose about Health Canada approval?

Dr. Reddy’s disclosed it has not yet received Health Canada’s Notice of Compliance for its Semaglutide Injection. The company confirmed a media headline about still awaiting approval and emphasized that the regulatory review process remains ongoing at this stage.

Has Dr. Reddy’s (RDY) Semaglutide Injection received any Health Canada identifiers?

Yes. Dr. Reddy’s reported receiving Drug Identification Numbers (DINs) for its Semaglutide Injection from Health Canada on April 22, 2026. These DINs are part of the regulatory review process and do not themselves constitute full marketing approval.

How did Dr. Reddy’s respond to the CNBC TV18 news item about Semaglutide?

The company confirmed the headline of the CNBC TV18 news item was correct, namely that it is still awaiting a major near-term trigger in the form of Health Canada approval for Semaglutide Injection. It used the disclosure to clarify the current regulatory status.

What is Dr. Reddy’s plan for Semaglutide Injection in the Canadian market?

Dr. Reddy’s said it continues to engage constructively with Health Canada and remains committed to bringing Semaglutide Injection to the Canadian market once approval is granted. The timing will depend on completion of the ongoing regulatory review process.

Which regulations govern Dr. Reddy’s disclosure on this Semaglutide update?

The company referenced Regulation 30(11) of the SEBI Listing Regulations regarding media reports and Regulation 30 more broadly for material event disclosures. It explained that no material event currently exists requiring a Regulation 30 disclosure for this product.

Filing Exhibits & Attachments

1 document