Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 427
2: Name of authorisation holder ROSEMONT PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, UNITED KINGDOM

4: Legally registered address of authorisation holder ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, 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 22/03/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 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
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Manufacture of cytotoxic agents - Methotrexate disodium
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical