BSECompany Update1d ago · 23 Oct 2026, 08:41 pm

Intimation regarding USFDA Pre-Approval Inspection at the Company''s Manufacturing facility situated at Indore, Madhya Pradesh is attached herewith.

Gufic Biosciences Ltd · 509079

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Gufic Biosciences Ltd has informed that the USFDA conducted a pre-approval inspection at its manufacturing facility in Indore, Madhya Pradesh from October 15-23, 2026, and received 3 observations in Form FDA 483. The company will address these observations within the stipulated timeframe.

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Earnings Impact5/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk6/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment5/10

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Gufic Biosciences Ltd - 509079 - Intimation Regarding USFDA Pre-Approval Inspection At The Company'S Manufacturing Facility Situated At Indore, Madhya Pradesh

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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