Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 8794 |
|---|---|
| 2: Name of authorisation holder | MICROPHARM LIMITED |
| 3: Address(es) of manufacturing site(s) |
MICROPHARM LIMITED, UNITS B2, B1 & D1, ANTUR TEIFI BUSINESS PARK, NEWCASTLE EMLYN, SA38 9DB, UNITED KINGDOM MICROPHARM LIMITED, STATION ROAD INDUSTRIAL ESTATE, NEWCASTLE EMLYN, SA38 9BY, UNITED KINGDOM MICROPHARM LIMITED, CNWCAU, CILGERRAN, CARDIGAN, SA43 2SN, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | MICROPHARM LIMITED, STATION ROAD INDUSTRIAL ESTATE, NEWCASTLE EMLYN, SA38 9BY, 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 | 15/03/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MICROPHARM LIMITED, UNITS B2, B1 & D1, ANTUR TEIFI BUSINESS PARK, NEWCASTLE EMLYN, SA38 9DB, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.6 ] Other aseptically prepared products Viper Vet manufactured for trials in accordance with ATC |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MICROPHARM LIMITED, STATION ROAD INDUSTRIAL ESTATE, NEWCASTLE EMLYN, SA38 9BY, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.2 ] Immunological products |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
MICROPHARM LIMITED, CNWCAU, CILGERRAN, CARDIGAN, SA43 2SN, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products Special Requirements Immunoglobulin F(ab')2 |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |