Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Wed 11 Nov 2026 00:07:48 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2025-07-29

Print Preview

Print Preview (Short version)

Back To Search

National Authority Of Medicines And Health Products

CERTIFICATE NUMBER: FT053/MH/002/2023

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Portugal confirms the following:

The manufacturer: Eugia Sez Private Limited

Site address:

Plot No S5 b S6 And S7 Survey No 408-412 418-435 437-445 452-459, Tsiic Sez Polepalle Village, Jadcherla, Mahabubnagar, 509301, India

OMS Organisation Id. / OMS Location Id.: ORG-100040787 / LOC-100067094

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:Art.176.º n.º 4 of Decree-Law n.º 176/2006, 30 of August.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2017-09-15 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.6  Other: Powder injectable(en)

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical

Clarifying remarks (for public users):

- Manufacturing lines previously authorised inspection 16th-20th May 2016: DPI and Lyo Line 1. - Scope inspection 11th-15th September 2017: Addition of a new production line (Lyo line 2) as well as renewal of the certificate of the previously approved lines. Covers 3 manufacturing lines: DPI, Lyo line 1 and Lyo line 2. - Complete address: Plot No. S-5/B, S-6 & S-7, Survey No’s: 408 to 412, 418 to 435, 437 to 445, 452 to 459, TSIIC, SEZ, Polepalle Village, Jadcherla Mandal, Mahabubnagar District, 509301,Telangana State, India. - Based on the outcome of the inspection to performed from 11th to 15th of September 2023, and in order to conclude the inspection process, this GMP certificate is valid until 31st March 2024.

Withdrawal comments in English: Replaced by GMP certificate FT053/MH/001/2024 ref key 169914 following GMP inspection of september 2023

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.