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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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