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Institute For Standardization And Control Of Pharmaceuticals

CERTIFICATE NUMBER: 11/14

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel

The competent authority of Israel confirms the following:

The manufacturer: Teva Pharmaceutical Industries Ltd.

Site address:

Industrial Zone, 18, Eli Hurvitz Street, P. O. Box 353, Kfar Saba, 4410202, Israel

OMS Organisation Id. / OMS Location Id.: ORG-100000702 / LOC-100050445

Other

(Human) Conformity Assessment and Acceptance of Industrial Products (CAA) Agreement between the European Union and Israel

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-07-11 , it is considered that it complies with: The Good Manufacturing Practice requirements referred to in the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel

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. 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.

Part 2

Human Medicinal Products
Human Investigational 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
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   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
           1.2.1.6  Liquids for internal use
           1.2.1.13  Tablets
           1.2.1.17  Other: pellets(en)
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.5  Biotechnology products
                  Special Requirements:
                   7  Other: packaging (primary & secondary) only(en)
   1.3.2  Batch Certification (list of product types)
           1.3.2.5  Biotechnology products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.2  Capsules, soft shell
           1.5.1.6  Liquids for internal use
           1.5.1.13  Tablets
           1.5.1.17  Other non-sterile medicinal products: bulks of tablets & hard capsules(en)
   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

2.1.3 Chemical/Physical
2.1.4 Biological

2.2 Batch certification of imported medicinal products

   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.2  Importation of intermediate which undergoes further processing
   2.3.4  Other: Biological active substances(en)

Clarifying remarks (for public users):

● Regarding the sampling : sampling of raw materials (active substances, excipients) and packaging materials (including primary) is also performed by the plant's staff at another site: Ltd., 1 HaTe'ena St., Modi'in Region Ind Park, Shoham, 6085001, Israel (S.L.E. is a member of Teva group) ● The biotechnological products are imported as bulks ● QC testing of imported products is relevant to the IMPs only ● Regarding the IMPs: this GMP certificate is relevant to IMPS for phase III clinical trials only ; IMPs are not included in the ACAA between Israel and the EU

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.