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.
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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