Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 4543
2: Name of authorisation holder CP PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, UNITED KINGDOM

4: Legally registered address of authorisation holder CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, 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 16/09/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, 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)
        [ 1.1.1.2 ] Lyophilisates
        [ 1.1.1.4 ] Small volume liquids
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
        [ 1.1.2.3 ] Small volume liquids
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.17 ] Other non-sterile medicinal products
             Nasal Sprays
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.2 ] Immunological products
        [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.6 ] Human or animal extracted products
        [ 1.3.1.8 ] Other biological medicinal products
            manufacture of products based on botanical extracts and hormones
    [ 1.3.2 ] Batch certification
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products
        [ 1.3.2.8 ] Other biological medicinal products
            manufacture of products based on botanical extracts and hormones
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.4 ] Other
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.1 ] Filtration
        [ 1.4.2.2 ] Dry heat
        [ 1.4.2.3 ] Moist heat
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.17 ] Other non-sterile medicinal products
            Nasal spray
    [ 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
    [ 1.6.4 ] Biological
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
    [ 2.1.4 ] Biological
[ 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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation