FDA issues Form 483 after Dr. Reddy’s (NYSE: RDY) plant inspection

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories Limited reports that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at its FTO-SEZ Process Unit-02 facility in Srikakulam, Andhra Pradesh. The regulatory review was carried out between July 20, 2026 and July 29, 2026.

Following the inspection, the company received an FDA Form 483 containing three observations. Dr. Reddy’s states that these observations will be addressed within the stipulated timeline, and the update has been shared with the Indian stock exchanges and the New York Stock Exchange for information and records.

Key Figures

FDA inspection period: July 20, 2026 to July 29, 2026 Number of FDA Form 483 observations: 3 Inspection completion date: July 29, 2026

3 metrics

FDA inspection period July 20, 2026 to July 29, 2026 PAI and GMP inspection at FTO-SEZ Process Unit-02

Number of FDA Form 483 observations 3 Observations cited after inspection of FTO-SEZ Process Unit-02

Inspection completion date July 29, 2026 Date USFDA completed PAI and GMP inspection

Key Terms

Pre-Approval Inspection (PAI), Good Manufacturing Practices (GMP), Form 483

3 terms

Pre-Approval Inspection (PAI) regulatory

"USFDA today completed a Pre-Approval Inspection (PAI) and GMP inspection"

Good Manufacturing Practices (GMP) regulatory

"completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection"

Good manufacturing practices (GMP) are the set of rules and controls that ensure drugs, medical devices, and related products are made cleanly, consistently, and to the quality claimed on the label. For investors, GMP matters because meeting these standards reduces the chance of product recalls, production shutdowns, fines, or lost approvals—similar to a restaurant that follows strict recipes and hygiene to avoid food poisoning and keep customers coming back.

Form 483 regulatory

"We have been issued a Form 483 with three observations"

Form 483 is a written list of inspectional observations issued by the U.S. Food and Drug Administration when inspectors spot potential problems during a facility visit, such as gaps in manufacturing, recordkeeping, or safety controls. For investors it matters because receiving a Form 483 signals possible regulatory trouble that can lead to remediation costs, production delays, product holds or fines—similar to a visible warning sign that a company must fix operations to stay compliant.

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

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FAQ

What did Dr. Reddy’s Laboratories (RDY) disclose about the recent USFDA inspection?

Dr. Reddy’s disclosed that the USFDA completed a PAI and GMP inspection at its FTO-SEZ Process Unit-02 in Srikakulam from July 20–29, 2026. The company received a Form 483 with three observations, which it plans to address within the stipulated timeline.

What is the outcome of the USFDA inspection mentioned by Dr. Reddy’s (RDY)?

The outcome was the issuance of an FDA Form 483 with three observations for Dr. Reddy’s FTO-SEZ Process Unit-02. The company indicates it will address all three observations within the required timeframe following the Pre-Approval and GMP inspection.

When did the USFDA inspection at Dr. Reddy’s (RDY) Srikakulam facility take place?

The USFDA conducted the inspection between July 20, 2026 and July 29, 2026. This period covered both a Pre-Approval Inspection (PAI) and a GMP inspection at Dr. Reddy’s FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh.

Which Dr. Reddy’s (RDY) facility was inspected by the USFDA in July 2026?

The inspection covered Dr. Reddy’s FTO-SEZ Process Unit-02 located in Srikakulam, Andhra Pradesh. The USFDA completed both PAI and GMP reviews at this manufacturing site, later issuing a Form 483 with three observations for the company to address.

How many FDA Form 483 observations did Dr. Reddy’s (RDY) receive, and what is the company’s response?

Dr. Reddy’s received three observations in the FDA Form 483 issued after the inspection. The company states that it will address these three observations within the stipulated timeline and has informed all its listed stock exchanges of this development.

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

July, 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 July 29, 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: July 29, 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

July 29, 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 you that the United States Food & Drug Administration (USFDA) today completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at our FTO-SEZ Process Unit-02, Srikakulam, Andhra Pradesh. The inspection was conducted between July 20, 2026, and July 29, 2026. We have been issued a Form 483 with three observations, which we will address 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 21.3 KB