Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 20072
2: Name of authorisation holder AMDIPHARM UK LIMITED
3: Address(es) of manufacturing site(s)

AMDIPHARM UK LIMITED, CAPITAL HOUSE, 85 KING WILLIAM STREET, LONDON, EC4N 7BL, UNITED KINGDOM

AMDIPHARM UK LIMITED, DASHWOOD HOUSE, 69 OLD BROAD STREET, LONDON, EC2M 1QS, UNITED KINGDOM

4: Legally registered address of authorisation holder AMDIPHARM UK LIMITED, DASHWOOD HOUSE, 69 OLD BROAD STREET, LONDON, EC2M 1QS, 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 23/11/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AMDIPHARM UK LIMITED, CAPITAL HOUSE, 85 KING WILLIAM STREET, LONDON, EC4N 7BL, 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
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.2 ] Batch certification
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 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
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

AMDIPHARM UK LIMITED, DASHWOOD HOUSE, 69 OLD BROAD STREET, LONDON, EC2M 1QS, 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
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.2 ] Batch certification
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 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