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.

Analysis Scores

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