Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK ManA 12845 |
|---|---|
| 2: Name of authorisation holder | SPRINGDEW LIMITED |
| 3: Address(es) of manufacturing site(s) |
SPRINGDEW LIMITED, UNITS 11/12, WOODLANDS BUSINESS PARK, YSTRADGYNLAIS, SWANSEA, SA9 1JW, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SPRINGDEW LIMITED, UNITS 11/12, WOODLANDS BUSINESS PARK, YSTRADGYNLAIS, SWANSEA, SA9 1JW, 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 | 12/07/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
SPRINGDEW LIMITED, UNITS 11/12, WOODLANDS BUSINESS PARK, YSTRADGYNLAIS, SWANSEA, SA9 1JW, UNITED KINGDOM
Veterinary Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| 1. MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile products |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |