NSEGeneral Updates23 Oct 2026 · 23 Oct 2026, 08:48 pm

General Updates

Gufic Biosciences Limited · GUFICBIO

✦ AI SummaryRegulatory

Gufic Biosciences Limited has informed the Exchange about a USFDA Pre-Approval Inspection at its manufacturing facility in Indore, Madhya Pradesh, which resulted in 3 observations in Form FDA 483. The company will work with USFDA to address these observations within the stipulated timeframe.

Analysis Scores

Earnings Impact2/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk6/10
Balance Sheet Risk1/10
Liquidity Impact5/10
Market Sentiment4/10

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Full Announcement

Gufic Biosciences Limited has informed the Exchange about Intimation regarding USFDA Pre-Approval Inspection at the Company s Manufacturing facility situated at Indore, Madhya Pradesh

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GUFIC_23102026204725_finalintimationUSFDA.pdf

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329/LG/SE/OCT/2026/GBSL October 23, 2026 To, To, BSE Limited, National Stock Exchange of India Limited, Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex, Dalal Street, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051 Scrip Code: 509079 Scrip Symbol: GUFICBIO Subject: Intimation regarding USFDA Pre-Approval Inspection at the Company’s Manufacturing facility situated at Indore, Madhya Pradesh Dear Sir/Madam, Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we hereby inform you that United States Food and Drug Administration (USFDA) conducted a Pre- Approval Inspection at the Company’s manufacturing facility located at Plot no. 48, Smart Industrial Park, Near Natrip, Pithampur, District Dhar – 454775, Indore, Madhya Pradesh from October 15, 2026 to October 23, 2026. Upon conclusion of the inspection, the Company received 3(three) observations in Form FDA 483. The Company will work closely with the USFDA and remains committed to addressing the observations comprehensively within the stipulated timeframe. Kindly take the same on record. Thanking You, Yours truly, For Gufic Biosciences Limited Ami Shah Company Secretary & Compliance Officer Membership No. A39579