Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 25
2: Name of authorisation holder ORGANON PHARMA (UK) LIMITED
3: Address(es) of manufacturing site(s)

ORGANON PHARMA (UK) LIMITED, SHOTTON LANE, CRAMLINGTON, NE23 3JU, UNITED KINGDOM

4: Legally registered address of authorisation holder ORGANON PHARMA (UK) LIMITED, THE HEWETT BUILDING, 14 HEWETT STREET, LONDON, EC2A 3NP, 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 17/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

ORGANON PHARMA (UK) LIMITED, SHOTTON LANE, CRAMLINGTON, NE23 3JU, 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)
        [ 1.2.1.8 ] Other solid dosage forms
Special Requirements
            Bulk Granules and bulk blend for oral solution.
        [ 1.2.1.13 ] Tablets
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.8 ] Other solid dosage forms
            Special Requirements
            Bulk Granules and bulk blend for oral solution.
        [ 1.5.1.13 ] Tablets
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical