Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 59749 |
|---|---|
| 2: Name of authorisation holder | 4BASEBIO UK LTD |
| 3: Address(es) of manufacturing site(s) |
4BASEBIO UK LTD, UNIT 12 & UNIT 18, MERIDIAN, BUCKINGWAY BUSINESS PARK, ANDERSON ROAD, SWAVESEY, CAMBRIDGE, CB24 4AE, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | 4BASEBIO UK LTD, UNIT 25, NORMAN WAY INDUSTRIAL ESTATE, NORMAN WAY, OVER, CAMBRIDGE, CB24 5QE, 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 | 31/03/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
4BASEBIO UK LTD, UNIT 12 & UNIT 18, MERIDIAN, BUCKINGWAY BUSINESS PARK, ANDERSON ROAD, SWAVESEY, CAMBRIDGE, CB24 4AE, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products ATMP Manufacture- a) Critical Starting Material- CDMO Manufacturing of Synthetic DNA template for IMP drug substance manufacturing b) Drug Substance- CDMO Manufacturing of Synthetic DNA for IMP drug product |