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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 007/2026/RO

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

Part 1

Issued following an inspection in accordance with
Art. 15 of Directive 2001/20/EC as amended

The competent authority of Romania confirms the following:

The manufacturer: Sindan Pharma S.R.L.

Site address:	Bulevardul Mihalache Ion 11, Bucharest, 011171, Romania
Additional details on units inspected:	*SINDAN-PHARMA SRL, complete address: B-dul Ion Mihalache nr. 11, sector 1, Bucureşti, cod 011171, România*

OMS Organisation Id. / OMS Location Id.: ORG-100008349 / LOC-100014751

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 14F in accordance with Art. 13 of Directive 2001/20/EC, transposed in the following national legislation:art. 48 from Minister of Public Health Order no. 904/2006 for approval of Regulations relating the implementation of Good clinical practice in the conduct of clinical trials on medicinal products of human use.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2026-01-23 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (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. 15 of Directive 2001/20/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 Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.2 Non-sterile products

1.2.2 Batch certification

1.3 Biological medicinal products (list of product types)

1.3.2 Batch Certification (list of product types)
1.3.2.5 Biotechnology products

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

partial manufacturing operations are carried out - batch certification for human investigational medicinal products, belonging to Sindan-Pharma SRL Romania, manufactured, tested and packaged primarily by Sindan-Pharma SRL Romania, as mentioned in Annex no.8; (missing text) only the import of retention samples of human investigational medicinal products (bulk/intermediate products and secondary packaging/labelled products) is carried out for the batch certification of human investigational medicinal products, mentioned in Annex no.8; the physical place of storage of the imported retention samples of human investigational medicinal products (bulk/intermediate products and secondary packaging/labelled products) is the working point of Sindan-Pharma SRL in Şos. Odăi nr.179-185, Sector 1, cod poștal 013604, Bucureşti. This GMP certificate is valid up to January 2029.

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.