FDA PLI at Dr. Reddy’s (NYSE: RDY) biologics site yields 7 observations

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories Limited reports that the United States Food & Drug Administration has completed a Pre-License Inspection at its biologics manufacturing facility in Bachupally, Hyderabad. The inspection, conducted from June 16 to June 25, 2026, resulted in a Form 483 with seven observations.

The company states it will address these observations within the stipulated timeline. This update follows earlier inspections and related disclosures made to stock exchanges on October 12, 2023 and September 13, 2025, and is provided for information of investors and exchanges.

Insights

Regulatory affairs analyst

FDA PLI completed at Dr. Reddy’s biologics site with seven Form 483 observations.

The United States Food & Drug Administration completed a Pre-License Inspection of Dr. Reddy’s Bachupally biologics facility between June 16 and June 25, 2026. After the inspection, the agency issued a Form 483 listing seven observations the company must remediate.

Form 483 observations highlight areas where inspectors believe practices may not fully meet regulatory expectations. The company indicates it will address all seven observations within the stipulated timeline, suggesting a structured response process is underway, but the filing does not quantify potential timing or commercial impact.

This PLI is linked to earlier inspections disclosed on October 12, 2023 and September 13, 2025, indicating ongoing regulatory engagement at the Bachupally biologics site. Subsequent company communications and regulatory updates will clarify how resolving these observations affects licensing progress for the associated biologic products.

Key Figures

Form 483 observations: 7 observations Inspection period start: June 16, 2026 Inspection period end: June 25, 2026 +2 more

5 metrics

Form 483 observations 7 observations Issued after FDA Pre-License Inspection at Bachupally biologics facility

Inspection period start June 16, 2026 Start date of FDA Pre-License Inspection

Inspection period end June 25, 2026 End date of FDA Pre-License Inspection and Form 483 issuance

Prior inspection disclosure date 1 October 12, 2023 Earlier inspection disclosure referenced as related

Prior inspection disclosure date 2 September 13, 2025 Earlier inspection disclosure referenced as related

Key Terms

Pre-License Inspection (PLI), Form 483, biologics manufacturing facility, foreign private issuer, +1 more

5 terms

Pre-License Inspection (PLI) regulatory

"the United States Food & Drug Administration (USFDA) today completed a Pre-License Inspection (PLI) at our biologics manufacturing facility"

Form 483 regulatory

"We have been issued a Form 483 with seven observations, which we will address"

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.

biologics manufacturing facility technical

"completed a Pre-License Inspection (PLI) at our biologics manufacturing facility in Bachupally, Hyderabad"

foreign private issuer regulatory

"REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-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.

Form 6-K regulatory

"SECURITIES AND EXCHANGE COMMISSION Form 6-K REPORT OF FOREIGN PRIVATE ISSUER"

A Form 6-K is a report that companies listed in certain countries file to provide important updates, such as financial results, corporate changes, or other significant information, to regulators and investors. It functions like an official company update or news release, helping investors stay informed about developments that could affect their investment decisions.

FAQ

What did the FDA do at Dr. Reddy’s (RDY) Bachupally biologics facility?

The United States Food & Drug Administration completed a Pre-License Inspection at Dr. Reddy’s Bachupally biologics manufacturing facility. The inspection ran from June 16 to June 25, 2026, and evaluated compliance ahead of potential product licensing.

How many FDA Form 483 observations did Dr. Reddy’s (RDY) receive?

Dr. Reddy’s received a Form 483 with seven observations following the FDA’s Pre-License Inspection. The company states it will address all seven observations within the stipulated timeline, but this filing does not detail the specific issues or corrective actions.

Over what period did the FDA inspect Dr. Reddy’s Bachupally biologics plant?

The FDA’s Pre-License Inspection at Dr. Reddy’s Bachupally biologics facility was conducted between June 16 and June 25, 2026. This multi-day review assessed the site’s readiness and compliance in connection with biologic product licensing activities.

How is Dr. Reddy’s (RDY) responding to the FDA Form 483 observations?

Dr. Reddy’s states it will address the seven Form 483 observations within the stipulated timeline. While specific corrective steps are not described here, this indicates the company plans formal remediation and interaction with the FDA following the inspection.

How does this FDA inspection relate to Dr. Reddy’s prior regulatory disclosures?

The company notes this Pre-License Inspection and Form 483 are in continuation of earlier inspections and disclosures made on October 12, 2023 and September 13, 2025. This highlights an ongoing regulatory review process at the Bachupally biologics facility.

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

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Form 6-K: How Foreign Companies Report to the SEC →

Available on EDGAR 06/26/2026 - 11:59 AM Accepted by SEC EDGAR 06/26/2026 - 11:59 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

June, 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 June 25, 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: June 25, 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

June 25, 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-License Inspection (PLI) at our biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted between June 16 and June 25, 2026. We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline. This is also in continuation of the earlier inspections and corresponding disclosures made to the stock exchanges on October 12, 2023 and September 13, 2025.

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 19.5 KB