Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 18480 |
|---|---|
| 2: Name of authorisation holder | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, UNITED KINGDOM FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, 1 UNION SQUARE, CENTRAL PARK, DARLINGTON, DL1 1GL, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, 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 | 29/07/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, BELASIS AVENUE, BILLINGHAM, TS23 1LH, 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 |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Manufacturing of recombinant protein and nucleotide intermediates and active pharmaceutical ingredients, master/working cell banks and master/working non-pathogenic viral banks/seed lots, storage of these and samples for testing |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, 1 UNION SQUARE, CENTRAL PARK, DARLINGTON, DL1 1GL, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.4 ] Gene therapy products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Manufacturing of recombinant protein and nucleotide intermediates and active pharmaceutical ingredients, master/working cell banks and master/working non-pathogenic viral banks/seed lots, storage of these and samples for testing |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other Recombinant protein and nucleotide intermediates and active |