BSECompany Update2d ago · 23 Oct 2026, 04:21 pm

Conclusion of USFDA Unannounced Inspection at Company''s Formulation Facility at Dundigal, Hyderabad

Gland Pharma Ltd · 543245

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Gland Pharma Ltd has concluded an unannounced inspection by the USFDA at its Dundigal formulation facility, resulting in four Form 483 observations. These observations are procedural in nature and the company will submit corrective and preventive actions within the stipulated period.

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

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Gland Pharma Ltd - 543245 - Conclusion Of USFDA Unannounced Inspection At Company''s Formulation Facility At Dundigal, Hyderabad

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GLAND PHARMA LIMITED GLAND October 23, 2026 BSE Limited National Stock Exchange of India Limited Corporate Relationship Department Listing Department Phiroze Jeejeebhoy Towers Exchange Plaza, 5th floor 25th floor, Dalal Street Plot no. C-1, Block G, Bandra Kurla Complex Bandra Mumbai - 400 001 (East), Mumbai - 400 051 Scrip Code: 543245 Symbol: GLAND (ISIN: INE068V01023) Dear Sir/Madam, Sub: Conclusion of USFDA Unannounced Inspection at Company’s Dundigal Formulation Facility This is to inform you that the United States Food and Drug Administration (USFDA) has conducted an unannounced inspection on Current Good Manufacturing Practice (cGMP) at the Company’s Formulation Facility at Dundigal between October 12, 2026 and October 23, 2026. The said inspection was concluded with four (4) Form 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity. The information required as per Regulation 30 read with Schedule III Para A Sub Para 20 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 are provided in Annexure A enclosed herewith. Request to take the above information on record. Yours truly, For Gland Pharma Limited Sampath Kumar Pallerlamudi Company Secretary & Compliance Officer Encl: Annexure A Regd. Office: Corporate Office: Survey No. 143-148, 150 & 151, Near Gandimaisamma 'X' Roads Plot No. 11 & 84, TSIIC Phase: IV D.P. Pally, Dundigal, Dundigal-Gandimaisamma Mandal Pashamylaram (V), Patancheru (M), Sangareddy District Medchal-Malkajgiri District, Hyderabad 500043,Telangana, India Hyderabad 502307, Telangana, India Tel: +91-40-30510999 Fax: +91 0-30510800 Tel: +91-8455-699999 CIN: L24239TG1978PLC002276 | email: gland@glandpharma.com; investors@glandpharma.com | www.glandpharma.com GLAND Continuation Sheet Annexure A SI. Particulars Remarks 1 Name of the authority United States Food and Drug Administration (USFDA) 2 Nature and details of the action(s) taken or order(s) Form 483 with four (4) Observations passed; 3 Date of receipt of direction or order, including any October 23, 2026 ad-interim or interim orders, or any other communication from the authority 4 Details of the violation(s)/contravention(s) Not Applicable committed or alleged to be committed 5 Impact on financial, operation or other activities of Not Applicable the listed entity, quantifiable in monetary terms to the extent possible