Uk Mhra Gmp
REGENERON PHARMACEUTICALS INCORPORATEDREGENERON PHARMACEUTICALS INCORPORATED – UK MHRA GMP Certificate UK GMP 25041 Insp GMP 25041/794754-0004[H]
Record Details
This Uk Mhra Gmp record concerns REGENERON PHARMACEUTICALS INCORPORATED, with an inspection on March 20, 2017, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- March 20, 2017
- Issued
- May 19, 2017
- MIA number
- UK GMP 25041
- Site address
- 81 COLUMBIA TURNPIKE, RENSSELAER, 12144, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.6 ] Other aseptically prepared productsmanufacture and purification of active pharmaceutical ingredient, formulation [ 1.3 ] Biological 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 [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products EU Products - Kevzara, Dupixent, Zaltrap, Elyea and Praluent
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ID · c644a88b-ff27-4b40-8be3-2e79a732fa0a
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