Uk Mhra Gmp
IPSEN BIOPHARM LIMITEDIPSEN BIOPHARM LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 3070 Insp GMP/GDP/IMP 3070/14720-0052[I]
Record Details
This Uk Mhra Gmp record concerns IPSEN BIOPHARM LIMITED, with an inspection on May 15, 2025, issued by the MHRA, covering drugs.
- Company
- IPSEN BIOPHARM LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- May 15, 2025
- Issued
- July 31, 2025
- MIA number
- UK MIA(IMP) 3070
- Site address
- ASH ROAD, WREXHAM INDUSTRIAL ESTATE, WREXHAM, LL13 9UF, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 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 products or manufacturing activity [ 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 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherImportation of QP certified IMPs from a country on the approved country for import list
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