Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 8553
2: Name of authorisation holder DR REDDY'S LABORATORIES (UK) LIMITED
3: Address(es) of manufacturing site(s)

DR REDDY'S LABORATORIES (UK) LIMITED, 6 RIVERVIEW ROAD, BEVERLEY, HU17 0LD, UNITED KINGDOM

4: Legally registered address of authorisation holder DR REDDY'S LABORATORIES (UK) LIMITED, 6 RIVERVIEW ROAD, BEVERLEY, HU17 0LD, 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 16/09/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

DR REDDY'S LABORATORIES (UK) LIMITED, 6 RIVERVIEW ROAD, BEVERLEY, HU17 0LD, 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
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
        [ 1.3.1.6 ] Human or animal extracted products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.6 ] Human or animal extracted products
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.13 ] Tablets
    [ 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
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.6 ] Human or animal extracted products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)
        Cytotoxics, Site of physical Importation to state Licensed as sterile and non-sterile products