Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 17857 |
|---|---|
| 2: Name of authorisation holder | PATHEON UK LIMITED |
| 3: Address(es) of manufacturing site(s) |
PATHEON UK LIMITED, 151 BROOK DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4SD, UNITED KINGDOM PATHEON UK LIMITED, KINGFISHER DRIVE, COVINGHAM, SWINDON, SN3 5BZ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | PATHEON UK LIMITED, KINGFISHER DRIVE, COVINGHAM, SWINDON, SN3 5BZ, 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 | 08/06/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
PATHEON UK LIMITED, 151 BROOK DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4SD, 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) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.12 ] Suppositories |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Sachets, powder, Cytostatics. |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Pharmaceutical dosage forms containing peptides, proteins, enzymes or other materials from human, animal or microbiological sources |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Sachets, powder, cytostatics |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
PATHEON UK LIMITED, KINGFISHER DRIVE, COVINGHAM, SWINDON, SN3 5BZ, 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 |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.2 ] Lyophilisates |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.6 ] Other aseptically prepared products Powder, Cephalsporins, Cytostatics, and Tazobactam Sodium |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.3 ] Small volume liquids |
| [ 1.1.2.5 ] Other terminally sterilised prepared products Terminally sterilised microspheres of TCA and PLGA presented in vial |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.4.2.3 ] Moist heat |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.1 ] Microbiological: sterility |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.1 ] Sterile Products |
| [ 2.2.1.1 ] Aseptically prepared |
| [ 2.2.1.2 ] Terminally sterilised |
| [ 2.2.2 ] Non-sterile products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.3 ] Biological Active Substance |
| [ 2.3.4 ] Other Biological active substances |