Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 52811
2: Name of authorisation holder KINDEVA DRUG DELIVERY LIMITED
3: Address(es) of manufacturing site(s)

KINDEVA DRUG DELIVERY LIMITED, DERBY ROAD, LOUGHBOROUGH, LE11 5SF, UNITED KINGDOM

4: Legally registered address of authorisation holder KINDEVA DRUG DELIVERY LIMITED, DERBY ROAD, LOUGHBOROUGH, LE11 5SF, 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 11/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

KINDEVA DRUG DELIVERY LIMITED, DERBY ROAD, LOUGHBOROUGH, LE11 5SF, UNITED KINGDOM

Human Investigational 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 investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.9 ] Pressurised preparations
        [ 1.2.1.15 ] Other non-sterile medicinal products
            Dry Powder Inhalers
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.9 ] Pressurised preparations
Special Requirements
            Dry Powder Inhalers
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation