Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK ManA 5451
2: Name of authorisation holder CATALENT MICRON TECHNOLOGIES LIMITED
3: Address(es) of manufacturing site(s)

CATALENT MICRON TECHNOLOGIES LIMITED , CROSSWAYS BOULEVARD, CROSSWAYS, DARTFORD, DA2 6QY, UNITED KINGDOM

4: Legally registered address of authorisation holder CATALENT MICRON TECHNOLOGIES LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, 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 11/04/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CATALENT MICRON TECHNOLOGIES LIMITED , CROSSWAYS BOULEVARD, CROSSWAYS, DARTFORD, DA2 6QY, UNITED KINGDOM

Veterinary Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
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
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Particle size reduction by Micronisation - milling of APIs, excipients and blends. Steroids and hormones are occasionally handled at the facility. No feedstuffs such as wheat, oil or soya will be processed and no pellets manufactured.
    [ 1.2.2 ] Batch certification
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.3 ] Other
            Particle size reduction by Micronisation - milling of APIs, excipients and blends. Steroids and hormones are occasionally handled at the facility. No Feedstuffs such as wheat, oil or soya will be processed and no pellets manufactured
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.17 ] Other non-sterile medicinal products
            APIs, excipients, blends, steroids and hormones
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical