Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 47357
2: Name of authorisation holder APOLLO PHARMA LIMITED
3: Address(es) of manufacturing site(s)

APOLLO PHARMA LIMITED, UNIT 1, IRWELL WORKS, LOWER WOODHILL ROAD, BURY, BL8 1AA, UNITED KINGDOM

4: Legally registered address of authorisation holder APOLLO PHARMA LIMITED, UNIT 1, IRWELL WORKS, LOWER WOODHILL ROAD, BURY, BL8 1AA, 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 01/04/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

APOLLO PHARMA LIMITED, UNIT 1, IRWELL WORKS, LOWER WOODHILL ROAD, BURY, BL8 1AA, 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)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.8 ] Other solid dosage forms
        [ 1.2.1.11 ] Semi-solids
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical