Medicines and Healthcare products Regulatory Agency
REGISTRATION OF MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ACTIVE SUBSTANCES TO BE USED AS STARTING MATERIALS IN MEDICINAL PRODUCTS FOR HUMAN USE
| 1. Registration Number | UK API 44301 |
| 2. Name or corporate name of registrant | CURIUM PHARMA UK LIMITED |
| 3. Permanent or legal address of registrant | CURIUM PHARMA UK LIMITED, SUITE G030, REGUS, GROUND FLOOR, BUILDING 1000, LAKESIDE NORTH HARBOUR, WESTERN ROAD, PORTSMOUTH, PO6 3EZ, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
CURIUM PHARMA UK LIMITED, C/O HAMMERSMITH RADIOPHARMACY, BURLINGTON DANES BUILDING, IMPERIAL COLLEGE LONDON, DU CANE ROAD WHITE CITY, LONDON, W12 0NN, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 03/05/2024 |
This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in MHRA-GMDP.
The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.
SCOPE OF REGISTRATION
CURIUM PHARMA UK LIMITED, C/O HAMMERSMITH RADIOPHARMACY, BURLINGTON DANES BUILDING, IMPERIAL COLLEGE LONDON, DU CANE ROAD WHITE CITY, LONDON, W12 0NN, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates
Special Requirements Radiopharmaceuticals | |
| D | Manufacture of Sterile Active Substance |
| D.1 Aseptically prepared
Special Requirements Radiopharmaceuticals | |
| E | General Finishing Steps |
| E.2 Primary Packaging
Special Requirements Radiopharmaceuticals | |
| E.3 Secondary Packaging
Special Requirements Radiopharmaceuticals | |
| F | Quality Control Testing |
| F.2 Microbiological testing (excluding sterility testing)
Special Requirements Radiopharmaceuticals | |
| F.3 Microbiological testing (including sterility testing)
Special Requirements Radiopharmaceuticals | |
| Other Activities The F18 process uses VHP as sanitisation, then filtration as the sterilisation step Special Requirements Radiopharmaceuticals |