Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
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
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
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