Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 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, UNIT B, LOGIE COURT, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, THE BRUCE BUILDING, CASTLE BUSINESS PARK, STIRLING, FK9 4TS, 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 | 11/02/2026 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, SCION HOUSE, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM
Human 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 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 Special Requirements Cytotoxics |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology 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. This list is only indicative of he product handled. Special Requirements: Other Cytotoxics Special Requirements Cytotoxics |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| 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 1
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, UNIT B, LOGIE COURT, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological 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. Special Requirements Cytotoxics |
| [ 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 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, THE BRUCE BUILDING, CASTLE BUSINESS PARK, STIRLING, FK9 4TS, UNITED KINGDOM
Human 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 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 |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological 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. This list is only indicative of he product handled. Special Requirements: Other Cytotoxics 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 |
| [ 1.3.2.8 ] Other biological medicinal products Plasmid, DNA, RNA, peptides, proteins and antibody products. This list is only indicative of he product handled. Special Requirements: Other Cytotoxics Special Requirements Cytotoxics |
| [ 1.4 ] Other products or manufacturing activity |
| [ 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 |
| [ 1.6.4 ] Biological |
| 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 |