Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 27794
2: Name of authorisation holder CENTRAL PHARMA CONTRACT PACKING LIMITED
3: Address(es) of manufacturing site(s)

CENTRAL PHARMA CELL AND GENE THERAPY LTD, UNITS C AND D, HOMEFIELD BUSINESS PARK, HOMEFIELD ROAD, HAVERHILL, CB9 8QP, UNITED KINGDOM

DENDRON BRANDS LIMITED, 94 RICKMANSWORTH ROAD, WATFORD, WD18 7JJ, UNITED KINGDOM

CENTRAL PHARMA (CONTRACT PACKING) LIMITED, CAXTON ROAD, BEDFORD, MK41 0XZ, UNITED KINGDOM

4: Legally registered address of authorisation holder CENTRAL PHARMA CONTRACT PACKING LIMITED, CAXTON ROAD, ELM FARM INDUSTRIAL ESTATE, BEDFORD, MK41 0XZ, 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 26/09/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CENTRAL PHARMA CELL AND GENE THERAPY LTD, UNITS C AND D, HOMEFIELD BUSINESS PARK, HOMEFIELD ROAD, HAVERHILL, CB9 8QP, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

DENDRON BRANDS LIMITED, 94 RICKMANSWORTH ROAD, WATFORD, WD18 7JJ, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.11 ] Semi-solids
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Hormones
[ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CENTRAL PHARMA (CONTRACT PACKING) LIMITED, CAXTON ROAD, BEDFORD, MK41 0XZ, 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
[ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
[ 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
        [ 1.2.1.5 ] 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
        [ 1.2.1.13 ] Tablets
        [ 1.2.1.17 ] Other non-sterile medicinal products
             pressurised aerosols and sterile products. Previously sealed hormones and cytotoxic/cytostatic products.
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.9 ] Pressurised preparations
        [ 1.5.1.13 ] Tablets
        [ 1.5.1.17 ] Other non-sterile medicinal products
            Assembly of pressurised aerosols and sterile products. Previously sealed hormones and cytotoxic/cytostatic products. Secondary packaging of penicillin.
    [ 1.5.2 ] Secondary packaging
[ 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
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing