Dr. Reddy’s reports USFDA VAI inspection outcome
Dr. Reddy’s Laboratories Limited reports the outcome of a United States Food & Drug Administration inspection at its formulations manufacturing facility FTO-SEZ PU01 in Srikakulam, Andhra Pradesh.
Rhea-AI Filing Summary
Dr. Reddy’s Laboratories Limited reports the outcome of a United States Food & Drug Administration inspection at its formulations manufacturing facility FTO-SEZ PU01 in Srikakulam, Andhra Pradesh. The company has received the Establishment Inspection Report on March 4, 2026.
The USFDA classified the inspection outcome as “Voluntary Action Indicated (VAI)” and stated that the inspection is officially closed under 21 CFR 20.64(d)(3). This update follows an earlier intimation dated December 12, 2025 about the same GMP and Pre-Approval Inspection.
Positive
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Negative
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Insights
USFDA inspection at a key facility is closed with a VAI classification.
Dr. Reddy’s Laboratories confirms that a GMP and Pre-Approval Inspection at its Srikakulam formulations facility FTO-SEZ PU01 has concluded. The company received the USFDA Establishment Inspection Report on March 4, 2026, documenting the inspection outcome.
The USFDA classified the result as “Voluntary Action Indicated (VAI)” and recorded the inspection as officially closed under 21 CFR 20.64(d)(3). This closes out the inspection first disclosed in the company’s December 12, 2025 intimation, with no further status details provided in this communication.
FAQ
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What did Dr. Reddy’s Laboratories (RDY) disclose in this Form 6-K?
Which Dr. Reddy’s facility was inspected by the USFDA?
What was the result of the USFDA inspection for Dr. Reddy’s (RDY)?
When did Dr. Reddy’s receive the Establishment Inspection Report (EIR)?
How is this USFDA inspection update linked to Dr. Reddy’s December 2025 intimation?
Which stock exchanges did Dr. Reddy’s inform about the USFDA inspection outcome?
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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
March, 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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99.1 | Intimation dated March 05, 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: March 05, 2026 | By: | /s/ K Randhir Singh | |
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| Name: | K Randhir Singh |
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| 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 |
March 5, 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 December 12, 2025, wherein we had informed regarding a GMP and a Pre-Approval Inspection (PAI) conducted by the United States Food & Drug Administration (USFDA) at our formulations manufacturing facility (FTO-SEZ PU01) in Srikakulam, Andhra Pradesh.
We wish to inform you that the Company has received the Establishment Inspection Report (EIR) on March 04, 2026. 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
Company Secretary, Compliance Officer & Head-CSR