Dr. Reddy's notes 2 FDA observations at Mexico plant
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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
Key Terms
Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act regulatory
Form FDA 2953 regulatory
records assessment regulatory
API manufacturing facility technical
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?
What were the results of the USFDA records assessment disclosed by RDY?
Which Dr. Reddy’s facility was covered by the 2026 USFDA assessment?
Over what period did USFDA conduct the assessment mentioned by RDY?
How is Dr. Reddy’s (RDY) responding to the USFDA observations?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 |
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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) | ||
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Date: September 11, 2026 | By: | /s/ K Randhir Singh | |
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| Name: | K Randhir Singh |
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| 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