Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 51718
2: Name of authorisation holder CLYDESDALE PHARMA LTD
3: Address(es) of manufacturing site(s)

CLYDESDALE PHARMA LTD, UNIT 3 - 4 CAMPBELL COURT, BRAMLEY, TADLEY, RG26 5EG, UNITED KINGDOM

4: Legally registered address of authorisation holder CLYDESDALE PHARMA LTD, UNIT 3 - 4 CAMPBELL COURT, BRAMLEY, TADLEY, RG26 5EG, 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 14/09/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CLYDESDALE PHARMA LTD, UNIT 3 - 4 CAMPBELL COURT, BRAMLEY, TADLEY, RG26 5EG, 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
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.2 ] Capsules, soft shell
        [ 1.2.1.3 ] Chewing gums
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.8 ] Other solid dosage forms
        [ 1.2.1.9 ] Pressurised preparations
        [ 1.2.1.11 ] Semi-solids
        [ 1.2.1.12 ] Suppositories
        [ 1.2.1.13 ] Tablets
        [ 1.2.1.14 ] Transdermal patches
    [ 1.2.2 ] Batch certification
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.3 ] Chemical/Physical
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.2 ] Non-sterile products