Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA 42415 |
|---|---|
| 2: Name of authorisation holder | AB BIOTECHNOLOGY LIMITED |
| 3: Address(es) of manufacturing site(s) |
AB BIOTECHNOLOGY LIMITED, PENTLANDS SCIENCE PARK, BUSH LOAN, PENICUIK, EH26 0PZ, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | AB BIOTECHNOLOGY LIMITED, PENTLANDS SCIENCE PARK, BUSH LOAN, PENICUIK, EH26 0PZ, 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 | 01/11/2023 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:
AB BIOTECHNOLOGY LIMITED, PENTLANDS SCIENCE PARK, BUSH LOAN, PENICUIK, EH26 0PZ, UNITED KINGDOM
Human Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Drug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products Drug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.3 ] Other Drug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |