Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 50416
2: Name of authorisation holder STERLING DEESIDE LIMITED
3: Address(es) of manufacturing site(s)

STERLING DEESIDE LIMITED, UNIT 103, TENTH AVENUE, ZONE 3, DEESIDE INDUSTRIAL ESTATE, DEESIDE, CH5 2UA, UNITED KINGDOM

4: Legally registered address of authorisation holder STERLING DEESIDE LIMITED, UNIT 103, TENTH AVENUE, ZONE 3, DEESIDE INDUSTRIAL ESTATE, DEESIDE, CH5 2UA, 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 27/04/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

STERLING DEESIDE LIMITED, UNIT 103, TENTH AVENUE, ZONE 3, DEESIDE INDUSTRIAL ESTATE, DEESIDE, CH5 2UA, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
    [ 1.6.4 ] Biological