Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 14023 |
|---|---|
| 2: Name of authorisation holder | CATALENT UK SWINDON ZYDIS LIMITED |
| 3: Address(es) of manufacturing site(s) |
CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | CATALENT UK SWINDON ZYDIS LIMITED, 1 GEORGE SQUARE, GLASGOW, G2 1AL, 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 | 09/05/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Other non-sterile medicinal products freeze-dried, tablets, API coating using acoustic mixing for preparation of drug product intermediate |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Specifically freeze dried tablets (Zydis oral dispersible tablets) |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |