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Wed 11 Nov 2026 15:12:47 BST

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The Certificate has been withdrawn, withdrawn date is : 2024-04-18

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National Authority Of Medicines And Medical Devices

CERTIFICATE NUMBER: 045/2023/RO

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

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 2023-08-25 , it is considered that it complies with:

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

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

Clarifying remarks (for public users):

partial manufacturing operations are carried out - batch certification of the series 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; partial manufacturing operations are carried out - batch certification of the series for biological medicinal products for clinical investigation (products obtained through biotechnology), belonging to the Teva Pharmaceuticals group, as mentioned in Annex no.8; the place of batch certification of the series of human investigational medicinal products is the Sindan-Pharma SRL working point in B-dul. Ion Mihalache nr. 11, Sector 1, cod poștal 011171, București, Romania. This GMP certificate is valid up to January 2026.

Withdrawal comments in English: correction

Withdrawal comments in National Language: corectie

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