BSECompany Update21 Aug 2026 · 21 Aug 2026, 07:07 pm

Completion of Unannounced USFDA Inspection at the facility of Caplin Steriles Limited (Company''s subsidiary)

Caplin Point Laboratories Ltd · 524742

✦ AI SummaryRegulatory

Caplin Point Laboratories Ltd informed about the completion of an unannounced US FDA inspection at its subsidiary Caplin Steriles Limited's manufacturing facility. The inspection was conducted between August 13, 2026, and August 21, 2026, and resulted in 10 observations, all of which are procedural in nature.

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Earnings Impact5/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk1/10
Liquidity Impact6/10
Market Sentiment5/10

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Caplin Point Laboratories Ltd - 524742 - General Updates

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August 21, 2026 BSE Limited National Stock Exchange of India Ltd., Department of Corporate Relationship Department of Corporate Services 1st Floor, New Trade Ring, Rotunda Building Exchange Plaza, 5th Floor, Phiroze Jeejeebhoy Towers C-1, Block G,Bandra Kurla Complex, Dalal Street, Mumbai- 400001 Bandra (E),Mumbai – 400 051 Scrip Code: 524742 S c r i p C o d e : C A P L I P O I N T . Dear Sir/Madam, Sub: Completion of Unannounced US FDA Inspection at the facility of Caplin Steriles Limited (Company’s Subsidiary) This is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 13, 2026, and August 21, 2026. At the end of the inspection, the Company received Form 483 with 10 (ten) observations. The observations are procedural in nature and does not pertain to data integrity and none of them were repeat observations. The Company is addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe. Kindly take the same on your records. Sincerely Yours For Caplin Point Laboratories Limited Venkatram G General Counsel & Company Secretary Membership No A23989