BSECompany Update4d ago · 6 Aug 2026, 04:32 pm

Please find attached herewith intimation about update on US FDA inspection at Company''s Manufacturing Facility Located at Amaliya, Daman.

Alkem Laboratories Ltd · 539523

✦ AI SummaryRegulatory

Alkem Laboratories Ltd has received an Official Action Indicated (OAI) status from the US FDA for its manufacturing facility at Amaliya, Daman, following a recent inspection. The facility had received seven observations in a Form FDA 483. The company continues to supply approved products to the US market and will work with the regulator to achieve full compliance.

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Earnings Impact2/10
Growth Catalyst1/10
Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk1/10
Liquidity Impact5/10
Market Sentiment4/10

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Alkem Laboratories Ltd - 539523 - Update On US FDA Inspection At Company'S Manufacturing Facility Located At Amaliya, Daman

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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