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 SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, THE BRUCE BUILDING, CASTLE BUSINESS PARK, STIRLING, FK9 4TS, UNITED KINGDOM SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, UNIT B, LOGIE COURT, 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 | 03/02/2026 |
| 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 |
| [ 1.1.3 ] Batch certification |
| [ 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 |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 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 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, THE BRUCE BUILDING, CASTLE BUSINESS PARK, STIRLING, FK9 4TS, 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) |
| [ 1.1.1.4 ] Small volume liquids Special Requirements cytotoxics |
| [ 1.1.1.6 ] Other aseptically prepared products Suspensions Special Requirements Cytotoxics |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.3 ] Cell therapy 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 antibody products. 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 |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| 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 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, UNIT B, LOGIE COURT, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.4 ] Gene therapy products |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.3.2.8 ] Other biological medicinal products Plasmid, DNA, RNA, peptides, proteins and antibody products. |
| [ 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 |