NSEAction(s) initiated or orders passed6 Aug 2026 · 6 Aug 2026, 06:43 pm

Action(s) initiated or orders passed

Dabur India Limited · DABUR

✦ AI SummaryRegulatory

Dabur India Limited has received a Warning Letter from the US FDA regarding data integrity and maintenance lapses at its Silvassa manufacturing plant. The company has maintained proactive and transparent engagement with the US FDA, providing regular progress updates on remediation activities. The company has completed substantial parts of its mitigating actions, including data integrity training and deployment of an additional independent resource. The issue concerns only a small part of the manufacturing plant related to export of private label products, which does not generate significant revenue for the company.

Analysis Scores

Earnings Impact2/10
Growth Catalyst3/10
Governance Concern4/10
Regulatory Risk8/10
Balance Sheet Risk2/10
Liquidity Impact8/10
Market Sentiment5/10

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Full Announcement

Dabur India Limited has informed the Exchange about Update on Action(s) initiated or orders passed

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DABUR_06082026184322_letter.pdf

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Ref: SEC/SE/2026-27 August 06, 2026 Corporate Relations Department Listing Department BSE Ltd. National Stock Exchange of India Ltd. Phiroze Jeejeebhoy Towers Exchange Plaza, 5th Floor Dalal Street, Plot No. C/1, G Block, Bandra Kurla Complex Mumbai- 400001 Bandra (E), Mumbai – 400051 BSE Scrip Code: 500096 NSE Scrip Symbol: DABUR Sub: Submission of information under Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015 Dear Sir/Madam, In continuation of our letters dated June 1, 2026 and June 11, 2026 and pursuant to provisions of Regulation 30 read with sub-para 20 of Para A of Part A of Schedule Ill of SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015 ("Listing Regulations") read with SEBI master circular no. HO/49/14/14(7)2025-CFD- POD2/I/3762/2026 issued on July 11, 2023 (last updated on January 30, 2026), please find below updates related to action(s) taken or order(s) passed: 1 Name of the authority United States Food & Drug Administration (“US FDA”) 2 Nature and details of the action(s) taken or As informed earlier vide our aforesaid letters, US FDA had order(s) passed inspected Company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain gaps on account of data integrity and maintenance lapses. Pursuant to observations noted by the authority, review of the Company’s responses and Establishment Inspection Report (EIR), US FDA had issued an Import Alert (IA) 66-40 on June 10, 2026 (received by the company via email), for drugs manufactured by the Company at the aforesaid plant. An intimation in this regard was filed with stock exchanges on June 11, 2026. Now, the Company is in receipt of a Warning Letter which summaries all above information and events. Issuing warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought additional details regarding the corrective and preventive action plan. It is submitted that the Company has maintained proactive and transparent engagement with the US FDA, providing regular progress updates on remediation activities. The Company has since provided four detailed progress updates in line with agreed timelines. To date, substantial parts of Company’s mitigating actions have already been completed. Such actions include data integrity training across the entire manufacturing operations, deployment of an additional independent resource responsible for continuous review, oversight, and monitoring of data integrity systems & controls to strengthen governance and prevent recurrence of identified gaps, closure of all observed infrastructure related gaps within 30 days. Also, a comprehensive retrospective risk assessment of impacted processes, systems and products have been completed. The Company has also engaged a reputed independent US- based compliance consulting firm to support assessment, implementation and verification of corrective actions, with a DABUR INDIA LIMITED, Punjabi Bhawan, 10, Rouse Avenue, New Delhi – 110 002, Tel.: +91 11 71206000 Fax: +91 11 23222051 Regd. Office: 8/3, Asaf Ali Road, New Delhi – 110 002 (India) CIN: L24230DL1975PLC007908, Email: corpcomm@dabur.com Website: www.dabur.com focus on ensuring sustainable and effective closure of all identified gaps. To further strengthen the remedial action plan and respond to US FDA queries, revised response was submitted and company is working to close the actions in committed timelines and has been sharing regular updates with US FDA. It is pertinent to note that the issue concerns only a small part of our manufacturing plant situated at Silvassa in relation to export of private label products, which does not generate significant revenue for the Company. Domestic products are not covered and not impacted by this. The aforesaid plant continues to be operational for domestic market. The Company remains fully committed to working closely with the US FDA and completing the remaining actions in accordance with regulatory expectations. 3 Date of receipt of direction or order, July 24, 2026 including any ad interim or interim orders, or any other communication from the authority 4 Details of the violation(s)/contravention(s) There is no violation(s)/contravention(s) committed or alleged committed or alleged to be committed to be committed. The US FDA warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought detailed corrective and preventive action plan. We will be responding to this warning letter in due prescribed timelines as part of our mitigating actions i.e. within 15 working days of receipt of notice. This is a serious matter and we are approaching a resolution as desired by the US FDA with utmost urgency and gravity that it deserves. 5 Impact on financial, operation or other There is no impact on financial, operation or other activities of activities of the listed entity, quantifiable in the Company due to this warning notice. The warning notice monetary terms to the extent possible concerns to only a small part of our manufacturing plant situated at Silvassa, Dadra and Nagar Haveli, in relation to export of private label products, which does not generate significant revenue for the Company. Domestic products are not covered and not impacted by this order. The aforesaid plant continues to be operational for domestic market. We are continuing to engage with the US FDA authority by providing detailed corrective and preventive action plans along with proactive and strong action on the ground to fix the identified gaps. In addition, multiple internal and external independent third party testing has shown no out- of- specification or any other concerns with any of Company’s products. We remain committed to product quality and consumer safety. We have taken effective action to implement alternate sourcing strategies for our US customers. 6 Explanation for delay in disclosure There is no material delay on the part of the Company as the Company was reviewing the notice with multiple internal and DABUR INDIA LIMITED, Punjabi Bhawan, 10, Rouse Avenue, New Delhi – 110 002, Tel.: +91 11 71206000 Fax: +91 11 23222051 Regd. Office: 8/3, Asaf Ali Road, New Delhi – 110 002 (India) CIN: L24230DL1975PLC007908, Email: corpcomm@dabur.com Website: www.dabur.com external stakeholders and was evaluating next steps in the matter. The above warning notice was received by the Company on July 24, 2026 at 10.03 p.m. The above information shall also be made available on the Company's website at www.dabur.com. This is for your kind information and records. Thanking You, Yours faithfully, For Dabur India Limited (Ashok Kumar Jain) Group Company Secretary and Chief Compliance Officer DABUR INDIA LIMITED, Punjabi Bhawan, 10, Rouse Avenue, New Delhi – 110 002, Tel.: +91 11 71206000 Fax: +91 11 23222051 Regd. Office: 8/3, Asaf Ali Road, New Delhi – 110 002 (India) CIN: L24230DL1975PLC007908, Email: corpcomm@dabur.com Website: www.dabur.com