Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 40211 |
|---|---|
| 2: Name of authorisation holder | SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED |
| 3: Address(es) of manufacturing site(s) |
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, SCION HOUSE, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, UNIT 10, SCION HOUSE, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 21/11/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, SCION HOUSE, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.2 ] Lyophilisates Special Requirements Cytotoxics |
| [ 1.1.1.4 ] Small volume liquids Special Requirements Cytotoxics |
| [ 1.1.1.6 ] Other aseptically prepared products Suspensions Special Requirements Cytotoxics |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.15 ] Other non-sterile medicinal products Lyophilisation of non-sterile active ingredients / excipients for use as starting materials in solid oral dosage manufacturing elsewhere Special Requirements Cytotoxics |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Plasmid, DNA, RNA. peptides. proteins and antibodies products. This list is only indicative of the product handled. Special Requirements Cytotoxics |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.4 ] Gene therapy products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |