Dr. Reddy’s FTO-3 plant receives four FDA observations

Dr. Reddy’s Laboratories Limited reported that the United States Food & Drug Administration completed a GMP inspection of its formulations manufacturing facility FTO-3 in Bachupally, Hyderabad.

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories Limited reported that the United States Food & Drug Administration completed a GMP inspection of its formulations manufacturing facility FTO-3 in Bachupally, Hyderabad. The inspection took place from August 6, 2026 to August 14, 2026. Following the inspection, the company received a Form 483 with four observations, which it states will be addressed within the stipulated timeline.

Key Figures

Number of Form 483 observations: 4 observations Inspection start date: August 6, 2026 Inspection end date: August 14, 2026 +1 more

4 metrics

Number of Form 483 observations 4 observations USFDA Form 483 issued after GMP inspection of FTO-3

Inspection start date August 6, 2026 Beginning of USFDA GMP inspection at FTO-3

Inspection end date August 14, 2026 Completion of USFDA GMP inspection at FTO-3

Form type Form 6-K Report of foreign private issuer under the Exchange Act

Key Terms

GMP inspection, Form 483, formulations manufacturing facility (FTO-3), foreign private issuer

4 terms

GMP inspection medical

"the United States Food & Drug Administration (USFDA) completed a GMP inspection"

Form 483 regulatory

"We have been issued a Form 483 with four 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.

formulations manufacturing facility (FTO-3) technical

"at our formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad"

foreign private issuer regulatory

"REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16"

A foreign private issuer is a company organized outside the United States that meets tests showing it is primarily foreign-controlled and therefore qualifies for a different set of U.S. reporting rules. For investors, that means the company files less frequent or differently formatted disclosures with U.S. regulators and may follow home-country accounting and governance practices, so buying its stock is like dining at a well-reviewed restaurant that follows its home kitchen’s rules instead of the local menu — you get access but should check what standards apply.

FAQ

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

What did Dr. Reddy’s Laboratories (RDY) announce in its August 2026 Form 6-K?

Dr. Reddy’s (RDY) announced completion of a USFDA GMP inspection at its FTO-3 formulations facility in Hyderabad, conducted from August 6–14, 2026, resulting in a Form 483 containing four observations that the company plans to address.

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

The USFDA inspected Dr. Reddy’s (RDY) formulations manufacturing facility FTO-3 in Bachupally, Hyderabad. The company described it as a formulations plant and reported that the inspection concluded with a Form 483 containing four observations.

What are the key dates of the USFDA GMP inspection disclosed by RDY?

Dr. Reddy’s (RDY) reported that the USFDA GMP inspection at its FTO-3 facility was conducted from August 6, 2026 to August 14, 2026. These dates cover the full inspection period leading to issuance of a Form 483.

How many observations did the USFDA issue to Dr. Reddy’s (RDY) after the FTO-3 inspection?

After the inspection of FTO-3, the USFDA issued Dr. Reddy’s (RDY) a Form 483 with four observations. The company stated it will address these observations within the stipulated timeline set by the regulator.

How does Dr. Reddy’s (RDY) plan to respond to the USFDA Form 483 observations?

Dr. Reddy’s (RDY) stated that it will address all four Form 483 observations within the stipulated timeline. The company did not provide further detail on specific corrective actions in this communication.

Which stock exchanges were notified by Dr. Reddy’s (RDY) about the USFDA inspection outcome?

Dr. Reddy’s (RDY) notified the National Stock Exchange of India, BSE Limited, the New York Stock Exchange, and NSE IFSC Ltd. about the completion of the USFDA GMP inspection and the issuance of a Form 483.

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

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Accepted by SEC EDGAR 08/17/2026 - 06:40 AM EDT 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

August, 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 August 14, 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: August 14, 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

August 14, 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) completed a GMP inspection at our formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad. The inspection was conducted from August 6, 2026 to August 14, 2026. We have been issued a Form 483 with four 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 15.6 KB