Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 17780 |
|---|---|
| 2: Name of authorisation holder | ZENTIVA PHARMA UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
ZENTIVA PHARMA UK LIMITED, FIRST FLOOR, ANDREWS HOUSE, COLLEGE ROAD, GUILDFORD, GU1 4QB, UNITED KINGDOM ALLOGA UK LIMITED, AMBER PARK 7A, UNIT CW72, FARMWELL LANE, SUTTON-IN-ASHFIELD, NG17 1BX, UNITED KINGDOM ALLOGA UK LIMITED, UNIT 5, FARMWELL LANE, SUTTON-IN-ASHFIELD, NG17 1BX, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ZENTIVA PHARMA UK LIMITED, 12 NEW FETTER LANE, LONDON, EC4A 1JP, 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 | 18/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ZENTIVA PHARMA UK LIMITED, FIRST FLOOR, ANDREWS HOUSE, COLLEGE ROAD, GUILDFORD, GU1 4QB, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.2 ] Batch certification |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.2 ] Non-sterile products |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ALLOGA UK LIMITED, AMBER PARK 7A, UNIT CW72, FARMWELL LANE, SUTTON-IN-ASHFIELD, NG17 1BX, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
ALLOGA UK LIMITED, UNIT 5, FARMWELL LANE, SUTTON-IN-ASHFIELD, NG17 1BX, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |