Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 17269
2: Name of authorisation holder PROTHERICS UK LIMITED
3: Address(es) of manufacturing site(s)

PROTHERICS UK LIMITED, BLAENWAUN FFOSTRASOL, LLANDYSUL, SA44 5JT, UNITED KINGDOM

4: Legally registered address of authorisation holder PROTHERICS UK LIMITED, BLAENWAUN FFOSTRASOL, LLANDYSUL, SA44 5JT, 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 17/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

PROTHERICS UK LIMITED, BLAENWAUN FFOSTRASOL, LLANDYSUL, SA44 5JT, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.6 ] Other aseptically prepared products
            formulated bulk product is manufactured at this site and transferred to an external contractor for sterile filtration, filling and lyophilisation.
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.6 ] Human or animal extracted products
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical