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Institute For Standardization And Control Of Pharmaceuticals

CERTIFICATE NUMBER: 149/9

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: Rotem Industries Ltd.

Site address:

Rotem Industrial Park, Mishor Yamin D N Arava, Dimona, 8680600, Israel

OMS Organisation Id. / OMS Location Id.: ORG-100040317 / LOC-100065813

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-07-20 , 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.

4. Other Activities - Active Substances:
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture of active substance intermediates 3.1.3 Salt formation / Purification steps : precipitation, crystallization General Finishing Steps 3.5.1 Physical processing steps: drying, milling 3.5.2 Primary Packing 3.5.3 Secondary Packaging Quality Control Testing 3.6.1 Physical / Chemical testing (some of these tests are outsourced) 3.6.2 Microbiological testing (these tests are outsourced)

Clarifying remarks (for public users):

This GMP certificates relates to Mannose triflatetetraacetate (1,3,4,6-tetra-O-acetyl-2-O-trifluoromethanesulfonyl-β-D-mannopyranose)

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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.