Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 1811
2: Name of authorisation holder BARD PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, UNITED KINGDOM

4: Legally registered address of authorisation holder BARD PHARMACEUTICALS LIMITED, UNIT 198, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0AB, 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 21/04/2023
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, 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)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.13 ] Tablets
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical