Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 17901
2: Name of authorisation holder ASTRAZENECA UK LIMITED
3: Address(es) of manufacturing site(s)

ASTRAZENECA UK LIMITED, CHARTER WAY, SILK ROAD BUSINESS PARK, MACCLESFIELD, SK10 2NA, UNITED KINGDOM

4: Legally registered address of authorisation holder ASTRAZENECA UK LIMITED, 1 FRANCIS CRICK AVENUE, CAMBRIDGE BIOMEDICAL CAMPUS, CAMBRIDGE, CB2 0AA, 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 04/08/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

ASTRAZENECA UK LIMITED, CHARTER WAY, SILK ROAD BUSINESS PARK, MACCLESFIELD, SK10 2NA, UNITED KINGDOM

Human 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 Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
        [ 1.1.1.5 ] Solids and implants
Special Requirements
            LHRH Agonist ( Zoladex)
        [ 1.1.1.6 ] Other aseptically prepared products
            LHRH Agonist (Solids and Implants)
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.13 ] Tablets
            Special Requirements
            Antioestrogen (Nolvadex)
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.13 ] Tablets
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.1 ] Microbiological: sterility
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing