WRAFTON LABORATORIES LIMITED – MIA(IMP) 12063
| Authorisation Number | UK MIA(IMP) 12063 |
| Category | MIA(IMP) |
| Holder | WRAFTON LABORATORIES LIMITED |
| Registered Address | WRAFTON LABORATORIES LIMITED, EXETER ROAD, WRAFTON, BRAUNTON, EX33 2DL, UNITED KINGDOM |
| Authorisation Date | Oct 24, 2025 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.2 1.2.1 1.2.1.1 1.2.1.13 1.2.1.15 1.2.1.8 1.2.2 1.5 1.5.1 1.5.1.1 1.5.1.13 1.5.1.2 1.5.1.8 1.5.2 1.6 1.6.2 1.6.3 |
| Importation Operations | 2.1 2.1.2 2.1.3 2.2 2.2.2 2.3 2.3.2 |
| MHRA Link | View on MHRA Website |
Sites (1)
WRAFTON LABORATORIES LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
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
1.2.1.8 — Other solid dosage forms
1.2.1.13 — Tablets
1.2.1.15 — Other non-sterile medicinal products
1.2.2 — Batch certification
1.5 — Packaging
1.5.1 — Primary packaging
1.5.1.1 — Capsules, hard shell
1.5.1.2 — Capsules, soft shell
1.5.1.8 — Other solid dosage forms
1.5.1.13 — Tablets
1.5.2 — Secondary packaging
1.6 — Quality control testing
1.6.2 — Microbiological: non-sterility
1.6.3 — Chemical/Physical
Importation
2.1 — Quality control testing of imported medicinal products
2.1.2 — Microbiological: non-sterility
2.1.3 — Chemical/Physical
2.2 — Batch certification of imported medicinal products
2.2.2 — Non-sterile products
2.3 — Other Importation Activities
2.3.2 — Importation of Intermediate which undergoes further processing
Content Preview
The source document is available on KeyPedia. Sign in to view.