NSEGeneral Updates6 Aug 2026 · 6 Aug 2026, 04:30 pm
General Updates
Alkem Laboratories Limited · ALKEM
✦ AI SummaryRegulatory
Alkem Laboratories Limited has informed the Exchange about an update on the US FDA inspection at its manufacturing facility located at Amaliya, Daman. The facility received a Form FDA 483 containing seven observations, and the US FDA has classified the inspection status as Official Action Indicated (OAI). The company continues to manufacture and supply approved products from the facility to the U.S. market.
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Earnings Impact5/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk3/10
Liquidity Impact6/10
Market Sentiment5/10
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Full Announcement
Alkem Laboratories Limited has informed the Exchange about Update on US FDA Inspection at Company s manufacturing facility located at Amaliya, Daman
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ALKEM_06082026162857_Intimation_USFDA_inspection_-_OAI_classification_Signed.pdf
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6th August, 2026
The Corporate Relationship Department National Stock Exchange of India Limited
BSE Limited Exchange Plaza,
Phiroze Jeejeebhoy Towers, Bandra Kurla Complex,
Dalal Street, Bandra East,
Mumbai 400 001. Mumbai 400 051.
Scrip Code: 539523 Scrip Symbol: ALKEM
Sub: Update on US FDA Inspection at Company’s manufacturing facility located at
Amaliya, Daman
Dear Sir/Madam,
This is in continuation of our earlier intimation dated May 2, 2026, regarding the US FDA
inspection conducted at the Company’s manufacturing facility located at Amaliya, Daman,
from April 20, 2026 to May 1, 2026, during which the Company received a Form FDA 483
containing seven (7) observations. The US FDA has now classified the inspection status of the
said facility as Official Action Indicated (OAI).
The Company continues to manufacture and supply approved products from the said facility
to the U.S. market.
We will work with the regulator to achieve fully compliant status.
Kindly take the same on record.
Sincerely,
For Alkem Laboratories Limited
Divya Mewani
Vice President – Legal & Deputy Company Secretary