Dr. Reddy’s (NYSE: RDY) gets USFDA VAI rating, inspection closed

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories Limited reports the outcome of a United States Food & Drug Administration inspection at its formulations manufacturing facility FTO-SEZ PU01 in Srikakulam, Andhra Pradesh. The company has received the Establishment Inspection Report on March 4, 2026.

The USFDA classified the inspection outcome as “Voluntary Action Indicated (VAI)” and stated that the inspection is officially closed under 21 CFR 20.64(d)(3). This update follows an earlier intimation dated December 12, 2025 about the same GMP and Pre-Approval Inspection.

Insights

Regulatory and compliance analyst

USFDA inspection at a key facility is closed with a VAI classification.

Dr. Reddy’s Laboratories confirms that a GMP and Pre-Approval Inspection at its Srikakulam formulations facility FTO-SEZ PU01 has concluded. The company received the USFDA Establishment Inspection Report on March 4, 2026, documenting the inspection outcome.

The USFDA classified the result as “Voluntary Action Indicated (VAI)” and recorded the inspection as officially closed under 21 CFR 20.64(d)(3). This closes out the inspection first disclosed in the company’s December 12, 2025 intimation, with no further status details provided in this communication.

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

March, 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 March 05, 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: March 05, 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

March 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

This is in reference to our intimation dated December 12, 2025, wherein we had informed regarding a GMP and a Pre-Approval Inspection (PAI) conducted by the United States Food & Drug Administration (USFDA) at our formulations manufacturing facility (FTO-SEZ PU01) in Srikakulam, Andhra Pradesh.

We wish to inform you that the Company has received the Establishment Inspection Report (EIR) on March 04, 2026. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)' and concluded that the inspection is officially closed under 21 CFR 20.64(d)(3).

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

FAQ

What did Dr. Reddy’s Laboratories (RDY) disclose in this Form 6-K?

Dr. Reddy’s Laboratories disclosed that the USFDA has completed its inspection of the company’s formulations facility FTO-SEZ PU01 in Srikakulam, Andhra Pradesh, and issued an Establishment Inspection Report classifying the outcome as “Voluntary Action Indicated (VAI).”

Which Dr. Reddy’s facility was inspected by the USFDA?

The inspection covered Dr. Reddy’s formulations manufacturing facility designated FTO-SEZ PU01 in Srikakulam, Andhra Pradesh. This facility was previously referenced in a December 12, 2025 intimation regarding a GMP and Pre-Approval Inspection conducted by the USFDA at the same site.

What was the result of the USFDA inspection for Dr. Reddy’s (RDY)?

The USFDA issued an Establishment Inspection Report on March 4, 2026, classifying the inspection outcome as “Voluntary Action Indicated (VAI)” and recording that the inspection of the Srikakulam formulations facility is officially closed under 21 CFR 20.64(d)(3).

When did Dr. Reddy’s receive the Establishment Inspection Report (EIR)?

Dr. Reddy’s received the Establishment Inspection Report on March 4, 2026. The company communicated this date in its disclosure to stock exchanges, noting that the report relates to the earlier USFDA GMP and Pre-Approval Inspection at its FTO-SEZ PU01 facility in Srikakulam.

How is this USFDA inspection update linked to Dr. Reddy’s December 2025 intimation?

In December 2025, Dr. Reddy’s informed exchanges about a GMP and Pre-Approval Inspection at the Srikakulam FTO-SEZ PU01 facility. The current update states that the USFDA has now issued the Establishment Inspection Report and classified the inspection outcome as “Voluntary Action Indicated (VAI).”

Which stock exchanges did Dr. Reddy’s inform about the USFDA inspection outcome?

Dr. Reddy’s sent this disclosure to the National Stock Exchange of India, BSE Limited, the New York Stock Exchange, and NSE IFSC Ltd., referencing the respective scrip or stock codes for DRREDDY and RDY in its March 5, 2026 communication.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 20.3 KB