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.
Positive
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Negative
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Insights
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
Key Terms
Pre-License Inspection (PLI) regulatory
Form 483 regulatory
biologics manufacturing facility technical
foreign private issuer regulatory
Form 6-K regulatory
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 |
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|
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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) | ||
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| |
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