Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 58117 |
|---|---|
| 2: Name of authorisation holder | PINNACLE IMP LIMITED |
| 3: Address(es) of manufacturing site(s) |
PINNACLE IMP LIMITED, ADVANCED TECHNOLOGY AND INNOVATION CENTRE, LOUGHBOROUGH UNIVERSITY SCIENCE AND ENTERPRISE PARK, 5 OAKWOOD DRIVE, LOUGHBOROUGH, LE11 3QF, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | PINNACLE IMP LIMITED, ADVANCED TECHNOLOGY AND INNOVATION CENTRE, LOUGHBOROUGH UNIVERSITY SCIENCE AND ENTERPRISE PARK, 5 OAKWOOD DRIVE, LOUGHBOROUGH, LE11 3QF, 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 | 24/09/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
PINNACLE IMP LIMITED, ADVANCED TECHNOLOGY AND INNOVATION CENTRE, LOUGHBOROUGH UNIVERSITY SCIENCE AND ENTERPRISE PARK, 5 OAKWOOD DRIVE, LOUGHBOROUGH, LE11 3QF, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.5 ] Solids and implants |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.2 ] Semi-solids |
| [ 1.1.2.3 ] Small volume liquids |
| [ 1.1.2.4 ] Solids and implants |
| [ 1.1.3 ] Batch certification |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.14 ] Transdermal patches |
| [ 1.2.2 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |