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    Gland Pharma Limited

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    Paras Malout
    Gland Pharma received a report from the US FDA closing their inspection of the company's Dundigal Facility in Hyderabad. The inspection covered Gland Pharma's quality systems and compliance with current good manufacturing practice regulations for medical devices. The inspection took place from August 22nd to 25th, 2022. Gland Pharma has now received an Establishment Inspection Report from the US FDA indicating that the inspection has concluded.

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    Gland Pharma Limited

    Uploaded by

    Paras Malout
    32 views1 page
    Gland Pharma received a report from the US FDA closing their inspection of the company's Dundigal Facility in Hyderabad. The inspection covered Gland Pharma's quality systems and compliance with current good manufacturing practice regulations for medical devices. The inspection took place from August 22nd to 25th, 2022. Gland Pharma has now received an Establishment Inspection Report from the US FDA indicating that the inspection has concluded.

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    Gland Pharma received a report from the US FDA closing their inspection of the company's Dundigal Facility in Hyderabad. The inspection covered Gland Pharma's quality systems and compliance with current good manufacturing practice regulations for medical devices. The inspection took place from August 22nd to 25th, 2022. Gland Pharma has now received an Establishment Inspection Report from the US FDA indicating that the inspection has concluded.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    32 views1 page

    Gland Pharma Limited

    Uploaded by

    Paras Malout
    Gland Pharma received a report from the US FDA closing their inspection of the company's Dundigal Facility in Hyderabad. The inspection covered Gland Pharma's quality systems and compliance with current good manufacturing practice regulations for medical devices. The inspection took place from August 22nd to 25th, 2022. Gland Pharma has now received an Establishment Inspection Report from the US FDA indicating that the inspection has concluded.

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    © All Rights Reserved
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    of 1

    GLAND GLAND PHARMA LIMITED

    January 4, 2023

    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
    Mumbai - 400 001 Bandra (East), Mumbai - 400 051
    Scrip Code: 543245 Symbol: GLAND (ISIN: INE068V01023)

    Dear Sir/Madam,

    Sub: Conclusion of US FDA Inspection at Dundigal Facility, Hyderabad


    Ref: Our Letter dated Aug 25, 2022

    Further to our intimation dated August 25, 2022; this is to inform you that following the Pre-Market
    Inspection covering US FDA’s Quality System/Current Good Manufacturing Practice regulations for
    Medical Devices (21 CFR Part 820) at the Company’s Dundigal Facility at Hyderabad from
    22nd August, 2022 to 25th August, 2022; the Company has received the Establishment Inspection
    Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological
    Health, US FDA indicating closure of the inspection.

    Request to take the above information on record.

    Yours truly,
    For Gland Pharma Limited
    KUMAR Digitally signed by KUMAR
    PALLERLAMUDI SAMPATH

    PALLERLAMUDI DN: cn=KUMAR PALLERLAMUDI


    SAMPATH, c=IN, o=Personal,
    [email protected]
    SAMPATH Date: 2023.01.04 11:38:00 +05'30'

    P Sampath Kumar
    Company Secretary and Compliance Officer

    Regd. Office: Corporate Office:


    Survey N o . 143-148, 1 5 0 & 151, N e a r Gandimaisamma ‘X’ Roads Plot N o . 11 & 84, T S I I C Phase: I V
    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: +91-40-30510800 Tel: +91-8455-699999

    CIN: L24239TG1978PLC002276 | email: [email protected]; [email protected] | www.glandpharma.com

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