Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA 36390
2: Name of authorisation holder CIPLA (EU) LIMITED
3: Address(es) of manufacturing site(s)

CIPLA (EU) LIMITED, DIXCART HOUSE, ADDLESTONE ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2LE, UNITED KINGDOM

4: Legally registered address of authorisation holder CIPLA (EU) LIMITED, DIXCART HOUSE, ADDLESTONE ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2LE, 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 27/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

CIPLA (EU) LIMITED, DIXCART HOUSE, ADDLESTONE ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2LE, UNITED KINGDOM

Human Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 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
    [ 2.3.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)
        Cold Chain Products