FDA closes review of Dr. Reddy’s UK API plant
Dr. Reddy’s Laboratories Limited reported the outcome of a United States Food & Drug Administration inspection at its active pharmaceutical ingredient manufacturing facility in Mirfield, West Yorkshire, United Kingdom.
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Rhea-AI Filing Summary
Dr. Reddy’s Laboratories Limited reported the outcome of a United States Food & Drug Administration inspection at its active pharmaceutical ingredient manufacturing facility in Mirfield, West Yorkshire, United Kingdom. The inspection has been classified as “Voluntary Action Indicated (VAI)”, and the USFDA has concluded and officially closed the inspection under 21 CFR 20.64(d)(3). This indicates the facility remains under normal regulatory status with only voluntary corrective actions, if any, expected from the company.
Positive
- USFDA inspection of Mirfield API facility closed with a Voluntary Action Indicated (VAI) classification, indicating no requirement for official regulatory action.
Negative
- None.
Key Terms
Voluntary Action Indicated (VAI) regulatory
GMP inspection regulatory
21 CFR 20.64(d)(3) regulatory
API manufacturing facility technical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the USFDA conclude about Dr. Reddy’s (RDY) Mirfield API facility inspection?
Which Dr. Reddy’s (RDY) site was inspected by the USFDA?
What does a VAI classification mean for Dr. Reddy’s (RDY)?
When did Dr. Reddy’s (RDY) initially disclose the USFDA Mirfield inspection?
Which exchanges were notified about the USFDA inspection outcome for Dr. Reddy’s (RDY)?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 |
| 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: August 14, 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 |
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 in reference to our intimation dated September 8, 2025, wherein we had informed regarding a GMP inspection conducted by the United States Food & Drug Administration (USFDA) at our API manufacturing facility in Mirfield, West Yorkshire, United Kingdom. We wish to inform you that 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