NSEUpdates21 Aug 2026 · 21 Aug 2026, 07:12 pm

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Caplin Point Laboratories Limited · CAPLIPOINT

✦ AI SummaryRegulatory

Caplin Point Laboratories Limited has informed the Exchange regarding 'Completion of Unannounced US FDA Inspection at the facility of Caplin Steriles Limited (Company's Subsidiary)'

Analysis Scores

Earnings Impact5/10
Growth Catalyst2/10
Governance Concern3/10
Regulatory Risk8/10
Balance Sheet Risk2/10
Liquidity Impact6/10
Market Sentiment5/10

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Full Announcement

Caplin Point Laboratories Limited has informed the Exchange regarding 'Completion of Unannounced US FDA Inspection at the facility of Caplin Steriles Limited (Company s Subsidiary)'.

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CAPLINPOINT_21082026191221_Stock_Exchange_intimation_of_USFDA_Audit_signed.pdf

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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