Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 49934 |
|---|---|
| 2: Name of authorisation holder | UPPERTON LIMITED |
| 3: Address(es) of manufacturing site(s) |
UPPERTON LIMITED, ALBERT EINSTEIN CENTRE, NOTTINGHAM SCIENCE AND TECHNOLOGY PARK, NOTTINGHAM, NG7 2TN, UNITED KINGDOM UPPERTON LIMITED, UNIT 3, 5 & 11 BEESTON BUSINESS PARK, TRENT GATEWAY, TECHNOLOGY DRIVE, BEESTON, NOTTINGHAM, NG9 1LA, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | UPPERTON LIMITED, ALBERT EINSTEIN CENTRE, NOTTINGHAM SCIENCE AND TECHNOLOGY PARK, NOTTINGHAM, NG7 2TN, 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 | 13/11/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
UPPERTON LIMITED, ALBERT EINSTEIN CENTRE, NOTTINGHAM SCIENCE AND TECHNOLOGY PARK, NOTTINGHAM, NG7 2TN, 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 |
| [ 1.2.1.6 ] Liquids for internal use Special Requirements Substance with hormonal activity |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Spray dried bulk intermediate pharmaceutical products for Oral, nasal and pulmonary administration. |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Spray dried bulk intermediate and finished products from recombinant sources. |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products Spray dried bulk intermediate and finished products from recombinant sources. |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.1 ] Herbal products Special Requirements GWP4202541 (API) in Acetone Solution |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Herbal |
| [ 1.5.2 ] Secondary packaging |
| [ 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:
UPPERTON LIMITED, UNIT 3, 5 & 11 BEESTON BUSINESS PARK, TRENT GATEWAY, TECHNOLOGY DRIVE, BEESTON, NOTTINGHAM, NG9 1LA, 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 |
| [ 1.2.1.6 ] Liquids for internal use Special Requirements Substance with hormonal activity |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.15 ] Other non-sterile medicinal products Spray dried bulk intermediate pharmaceutical products for oral, nasal and pulmonary administration |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Spray dried bulk intermediate and finished products from recombinant sources |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products Spray dried bulk intermediate and finished products from recombinant sources |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.1 ] Herbal products Special Requirements GWP4202541 (API) in Acetone solution |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Herbal |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |