Dr. Reddy's notes 2 FDA observations at Mexico plant

Rhea-AI Filing Summary

DR REDDYS LABORATORIES LTD (RDY) reports that the U.S. Food and Drug Administration completed a records assessment under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act at its API manufacturing facility, Industrias Químicas Falcón de México, S.A. de C.V., in Jiutepec, Morelos, Mexico. The assessment took place between July 17, 2026 and September 8, 2026. At the conclusion, the FDA issued a Form FDA 2953 with two observations, and the company states it will respond within the stipulated timeline.

Key Figures

Number of FDA observations: 2 observations Assessment start date: July 17, 2026 Assessment end date: September 8, 2026 +1 more

4 metrics

Number of FDA observations 2 observations Form FDA 2953 issued at conclusion of records assessment

Assessment start date July 17, 2026 Beginning of USFDA records assessment period

Assessment end date September 8, 2026 End of USFDA records assessment period

Assessment type Section 704(a)(4) records assessment Under the Federal Food, Drug, and Cosmetic Act

Key Terms

Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, Form FDA 2953, records assessment, API manufacturing facility

4 terms

Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act regulatory

"completed a records assessment under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act"

Form FDA 2953 regulatory

"the USFDA issued a Form FDA 2953 containing two observations"

records assessment regulatory

"has completed a records assessment under Section 704(a)(4)"

API manufacturing facility technical

"at our API manufacturing facility, Industrias Químicas Falcón de México"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did USFDA do at Dr. Reddy’s (RDY) Mexico API facility in 2026?

USFDA completed a records assessment under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act at Dr. Reddy’s API facility Industrias Químicas Falcón de México, S.A. de C.V. in Jiutepec, Morelos, Mexico, between July 17, 2026 and September 8, 2026.

What were the results of the USFDA records assessment disclosed by RDY?

At the end of the assessment, USFDA issued a Form FDA 2953 containing two observations for Dr. Reddy’s Mexico API facility. The company states it will respond to these observations within the stipulated timeline.

Which Dr. Reddy’s facility was covered by the 2026 USFDA assessment?

The assessment covered Dr. Reddy’s API manufacturing facility Industrias Químicas Falcón de México, S.A. de C.V., referred to as Dr. Reddy's Mexico, located in Jiutepec, Morelos, Mexico.

Over what period did USFDA conduct the assessment mentioned by RDY?

USFDA conducted the records assessment at Dr. Reddy’s Mexico API facility between July 17, 2026 and September 8, 2026, as stated in the company’s communication.

How is Dr. Reddy’s (RDY) responding to the USFDA observations?

Dr. Reddy’s states it will respond to the Form FDA 2953 observations within the stipulated timeline. No additional details on the response or potential impact are provided in this communication.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/14/2026 - 06:35 AM Accepted by SEC EDGAR 09/14/2026 - 06:35 AM Learn about SEC filing dates

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

September, 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 September 11, 2026

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: September 11, 2026	By:	/s/ K Randhir Singh
		Name:	K Randhir Singh
		Title:	Company Secretary

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

September 11, 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

This is to inform that the United States Food and Drug Administration (USFDA) has completed a records assessment under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act at our API manufacturing facility, Industrias Químicas Falcón de México, S.A. de C.V. (Dr. Reddy's Mexico), located in Jiutepec, Morelos, Mexico. The assessment was conducted between July 17, 2026 and September 8, 2026. At the conclusion of the assessment, the USFDA issued a Form FDA 2953 containing two observations, to which we will respond within the stipulated timeline.

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

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 22.7 KB