BSECompany Update5d ago · 14 Aug 2026, 06:52 pm
Intimation regarding completion of US FDA Inspection
Neuland Laboratories Ltd · 524558
✦ AI SummaryRegulatory
Neuland Laboratories Ltd has informed that the US FDA has inspected its Unit 3 manufacturing facility and issued a Form 483 with one observation regarding procedural improvements in water and environmental monitoring.
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Neuland Laboratories Ltd - 524558 - Intimation Regarding Completion Of US FDA Inspection
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August 14, 2026
BSE Limited The National Stock Exchange of India Ltd
Phiroze Jeejeebhoy Towers, 25th Floor, Dalal Exchange Plaza,
Street, Mumbai – 400 001 Bandra Kurla Complex
Bandra (E), Mumbai – 400 001
Scrip Code: 524558 Scrip Code: NEULANDLAB; Series: EQ
Dear Sir/Madam,
Sub: Intimation under Regulation 30 of the Securities and Exchange Board of India (Listing
Obligations and Disclosure Requirements) Regulations, 2015
We wish to inform you that the United States Food and Drug Administration (“US FDA”) has
inspected our Unit 3 manufacturing facility, located at Gaddapotharam village, Jinnaram,
Sangareddy District, from 10th to 14th of August 2026.
At the conclusion of the inspection, the US FDA issued a Form 483 with one observation. The
observation pertains to procedural improvements in water and environmental monitoring to
include new organisms beyond those listed in the United States Pharmacopeia (USP). The
Company will submit its response to the US FDA within the stipulated timelines.
This is for your information and records.
Thanking you
Yours Sincerely,
For Neuland Laboratories Limited
Sarada Bhamidipati
Company Secretary