Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK ManA 11724 |
|---|---|
| 2: Name of authorisation holder | ANDERSONBRECON (UK) LIMITED |
| 3: Address(es) of manufacturing site(s) |
ANDERSONBRECON (UK) LIMITED, UNIT 1, TALGARTH BUSINESS PARK, TREFECCA ROAD, TALGARTH, BRECON, LD3 0PQ, UNITED KINGDOM ANDERSONBRECON (UK) LIMITED, UNITS 2-7, WYE VALLEY BUSINESS PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, HR3 5PG, UNITED KINGDOM ANDERSONBRECON (UK) LIMITED, FOREST ROAD, HAY-ON-WYE, HEREFORD, HR3 5EH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | ANDERSONBRECON (UK) LIMITED, PHAROS HOUSE, WYE VALLEY BUSINESS PARK, BRECON PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, HR3 5PG, 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 | 25/03/2021 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
ANDERSONBRECON (UK) LIMITED, UNIT 1, TALGARTH BUSINESS PARK, TREFECCA ROAD, TALGARTH, BRECON, LD3 0PQ, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| 1. MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.4 ] Impregnated matrices |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.1.15 ] Intraruminal devices |
| [ 1.5.1.16 ] Veterinary premixes |
| [ 1.5.2 ] Secondary packaging |
ANDERSONBRECON (UK) LIMITED, UNITS 2-7, WYE VALLEY BUSINESS PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, HR3 5PG, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| 1. MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.3 ] Batch certification |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.4 ] Impregnated matrices |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.1.15 ] Intraruminal devices |
| [ 1.5.1.16 ] Veterinary premixes |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| 2. IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.3 ] Chemical/Physical |
ANDERSONBRECON (UK) LIMITED, FOREST ROAD, HAY-ON-WYE, HEREFORD, HR3 5EH, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| 1. MANUFACTURING OPERATIONS |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.4 ] Impregnated matrices |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.1.15 ] Intraruminal devices |
| [ 1.5.1.16 ] Veterinary premixes |
| [ 1.5.2 ] Secondary packaging |