Uk Mhra Gmp
BIOMARIN PHARMACEUTICAL INCORPORATEDBIOMARIN PHARMACEUTICAL INCORPORATED – UK MHRA GMP Certificate UK GMP 18972 Insp GMP 18972/11593-0005[H]
Record Details
This Uk Mhra Gmp record concerns BIOMARIN PHARMACEUTICAL INCORPORATED, with an inspection on August 12, 2013, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- August 12, 2013
- Issued
- September 30, 2013
- MIA number
- UK GMP 18972
- Site address
- GALLI DRIVE FACILITY, 46 GALLI DRIVE, NOVATO, 94949, 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 productsLow Bioburden Bulk Formulated Drug Substance for aseptic filling elsewhere [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.8 ] Other biological medicinal productsEnzyme replacement therapy [ 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 Aldurazyme; Naglazyme; Vimizin; Firdapse; Kuvan.
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ID · 327b00b5-ab7f-4b9b-a6c0-42788a240050
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