IPSEN BIOPHARM LIMITED – MIA(IMP) 3070
| Authorisation Number | UK MIA(IMP) 3070 |
| Category | MIA(IMP) |
| Holder | IPSEN BIOPHARM LIMITED |
| Registered Address | IPSEN BIOPHARM LIMITED, ASH ROAD, WREXHAM INDUSTRIAL ESTATE, WREXHAM, LL13 9UF, UNITED KINGDOM |
| Authorisation Date | Apr 22, 2026 |
| Legal Basis | InvestigationalPart 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] |
| Sites | 1 |
| Manufacturing Operations | 1.1 1.1.1 1.1.1.2 1.1.1.4 1.3 1.3.1 1.3.1.5 1.4 1.4.2 1.4.2.1 1.6 1.6.1 1.6.2 1.6.3 1.6.4 |
| Importation Operations | 2.3 2.3.2 2.3.4 |
| MHRA Link | View on MHRA Website |
Sites (1)
IPSEN BIOPHARM LIMITED
BOTH
Country: UNITED KINGDOMProduct Class: Human Investigational Medicinal Products
Manufacturing
1.1 — Sterile Investigational Medicinal Products
1.1.1 — Aseptically prepared (processing operations for the following dosage forms)
1.1.1.2 — Lyophilisates
1.1.1.4 — Small volume liquids
1.3 — Biological investigational medicinal products
1.3.1 — Biological medicinal products
1.3.1.5 — Biotechnology products
1.4 — Other investigational medicinal products or manufacturing activitiy
1.4.2 — Sterilisation of active substances/excipients/finished products:
1.4.2.1 — Filtration
1.6 — Quality control testing
1.6.1 — Microbiological: sterility
1.6.2 — Microbiological: non-sterility
1.6.3 — Chemical/Physical
1.6.4 — Biological
Importation
2.3 — Other Importation Activities
2.3.2 — Importation of Intermediate which undergoes further processing
2.3.4 — Other
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