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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 091/2025/RO

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 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. 40 of Directive 2001/83/EC, transposed in the following national legislation:art. 755 from Law no. 95/2006 regarding the reform in the field of health republished, Title XVIII, Medicinal product.

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. (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)
           1.1.1.5  Solids and implants
                  Special Requirements:
                   7  Other: beta – lactam antibiotics - penicillins(en)
   1.1.3  Batch certification

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
                  Special Requirements:
                   7  Other: corticosteroids(en)
           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
                  Special Requirements:
                   7  Other: corticosteroids(en)
           1.5.1.12  Suppositories
           1.5.1.13  Tablets
   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
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

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

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.2  Importation of intermediate which undergoes further processing
   2.3.4  Other: release for sale of imported medicinal products(en)

Clarifying remarks (for public users):

total manufacturing operations for human medicinal products-sterile products– aseptically prepared-solids and implants-beta–lactam antibiotics–penicillins are carried out in the building P11-PP;total manufacturing operations for human medicinal products–non–sterile products–tablets,film-coated tablets are carried out in the Tablet Manufacturing Facility,located in the building P9-C; (missing text) storage of cephalosporin raw materials is carried out in the building P28-D;storage of finished product (medicines) is carried out in the building P7-D and building P40-D;importation of intermediate products from India(Omeprazole 8,5 %,pellets); import of finished products-medicines according to Annex 8 to the Authorization for which testing and batch certification is carried out in Romania at la Antibiotice SA; storage of imported intermediate products is done in building P33-D;storage of imported finished products is done in building P7-D.This GMP certificate is valid up to September 2028.

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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.