Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 18480
2: Name of authorisation holder FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED
3: Address(es) of manufacturing site(s)

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, UNITED KINGDOM

4: Legally registered address of authorisation holder FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, 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 13/12/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.8 ] Other biological medicinal products
            Manufacturing of recombinant protein and nucleotide intermediates and active pharmaceutical ingredients, cell bank manufacturing, storage of (non-pathogenic) baculovirus seed bank for insect cell culture
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological