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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 092/2025/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: Antibiotice S.A.

Site address:	Str Valea Lupului Nr 1, Iasi, 707410, Romania
Additional details on units inspected:	*ANTIBIOTICE SA, complete site address: Str.Valea Lupului, nr.1, Municipiul Iaşi, Județ Iaşi, cod poștal 707410, România*

OMS Organisation Id. / OMS Location Id.: ORG-100004211 / LOC-100000275

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 30F 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 2025-09-19 , 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

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: beta - lactam antibiotics – penicillins; beta - lactam antibiotics - cephalosporins; other antibiotics(en)
           1.2.1.8  Other solid dosage forms: film-coated tablets, ovules(en)
           1.2.1.11  Semi-solids
           1.2.1.12  Suppositories
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: beta - lactam antibiotics – penicillins; beta - lactam antibiotics - cephalosporins; other antibiotics(en)
           1.5.1.8  Other solid dosage forms: film-coated tablets, ovules(en)
           1.5.1.11  Semi-solids
           1.5.1.12  Suppositories
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

total manufacturing operations are performed for human investigational medicinal products (used in phase I clinical trias or bioequivalence conducted in Centrul de Studii Clinice belonging to Antibiotice S., Iaşi) – non sterile products – tablets, film -coated tablets, capsules with beta - lactam antibiotics – penicillins, capsules with beta - lactam antibiotics – cephalosporins, capsules, capsules with non – beta – lactam antibiotics and other antibiotics, Suppositories, ovules, Semi-solids (ointments, creams, gels, cutaneous paste); partial manufacturing operations are performed for human investigational medicinal products - secondary packaging in the building P16-CEM-RA dedicated to Centrul de Studii Clinice. / This GMP certificate is valid up to September 2028.

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.