Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 39930
2: Name of authorisation holder PEPCEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

PEPCEUTICALS LIMITED, 4 FELDSPAR CLOSE, ENDERBY, LEICESTER, LE19 4JS, UNITED KINGDOM

4: Legally registered address of authorisation holder PEPCEUTICALS LIMITED, 4 FELDSPAR CLOSE, ENDERBY, LEICESTER, LE19 4JS, 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 26/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

PEPCEUTICALS LIMITED, 4 FELDSPAR CLOSE, ENDERBY, LEICESTER, LE19 4JS, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.4 ] Impregnated matrices
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.11 ] Semi-solids
    [ 1.2.2 ] Batch certification
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical