NSEGeneral Updates13 Jul 2026 · 13 Jul 2026, 06:41 pm

General Updates

Alembic Pharmaceuticals Limited · APLLTD

✦ AI SummaryRegulatory

Alembic Pharmaceuticals Limited has received a Warning Letter from the USFDA regarding observations on Informed Consent Form (ICF) in a bioequivalence study. The Company believes the Warning Letter does not impose any restriction on its operations and is coordinating with the Clinical Investigator to submit a response within the stipulated timeline.

Analysis Scores

Earnings Impact2/10
Growth Catalyst1/10
Governance Concern1/10
Regulatory Risk6/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment5/10

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Full Announcement

Alembic Pharmaceuticals Limited has informed the Exchange about General Updates Disclsoure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015

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APLLTD_13072026183614_APL_Warning_Letter_Reg_30_Signed.pdf

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Date: 13th July, 2026 To, To, The Manager, The Manager, Department of Corporate Services, Listing Department, BSE Limited National Stock Exchange of India Ltd. P. J. Towers, Dalal Street, ‘Exchange Plaza’, Bandra Kurla Complex, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051 Scrip Code:533573 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Further to the Company's disclosure dated 7th March 2025 regarding the completion of the USFDA inspection of its Bioequivalence Facility at Vadodara, we wish to inform that the Company has been made aware that the United States Food and Drug Administration ("USFDA") has issued a Warning Letter dated 10th July 2026 to the Clinical Investigator associated with a bioequivalence study conducted at the Company's Bioequivalence Facility. The inspection was conducted by the USFDA during the period from 3rd March 2025 to 7th March 2025. The Warning Letter pertains to observation regarding Informed Consent Form (ICF) in relation to a bioequivalence study. The observations do not relate to data integrity. Based on the Company's preliminary assessment, the Warning Letter does not impose any restriction on the operations of the Company's Bioequivalence Facility. The Company is coordinating with the Clinical Investigator for submission of an appropriate response to the USFDA within the stipulated timeline. The details as required under the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 is attached herewith as Annexure-I. We request you to kindly take the same on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited G Krishnan Chief Financial Officer Encl: A/a ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123 Annexure – ‘I’ 1 Name of the Authority United States Food and Drug Administration (USFDA). 2 Nature and details of the action(s) The Company has been informed that the taken or order(s) passed USFDA has issued a Warning Letter dated 10th July 2026 to the Clinical Investigator associated with a bioequivalence study conducted at the Company's Bioequivalence Facility. 3 Date of receipt of direction or The Company became aware of the order, including any ad-interim or Warning Letter on 12th July, 2026. interim orders, or any other communication from the authority 4 Details of the The Warning Letter pertains to violation(s)/contravention(s) observation regarding Informed Consent committed or alleged to be Form (ICF) in relation to a bioequivalence committed study. The observations do not relate to data integrity. 5 Impact on financial, operational or Based on the Company's preliminary other activities of the listed entity, assessment, no material financial impact quantifiable in monetary terms to has been identified at this stage. The the extent possible Company is evaluating the matter and is coordinating with the Clinical Investigator in relation to the response to the USFDA. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123