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Uk Mhra Gmp
•PROTHERICS UK LIMITED•June 23, 2025

PROTHERICS UK LIMITED – UK MHRA GMP Certificate UK MIA 17269 Insp GMP/IMP 17269/22626-0013[H]

Record Details

This Uk Mhra Gmp record concerns PROTHERICS UK LIMITED, with an inspection on June 23, 2025, issued by the MHRA, covering drugs.

Company
PROTHERICS UK LIMITED
Compliance status
GMPC
Certificate type
GMP/IMP
Inspection date
June 23, 2025
Issued
June 23, 2025
MIA number
UK MIA 17269
Site address
BLAENWAUN FFOSTRASOL, LLANDYSUL, SA44 5JT, UNITED KINGDOM
Country
UNITED KINGDOM
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 productsformulated bulk product is manufactured at this site and transferred to an external contractor for sterile filtration, filling and lyophilisation. [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.6 ] Human or animal extracted products [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
Restrictions
This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · 9e2b7494-4840-4a52-a3b2-a5c41d357867

Other documents for PROTHERICS UK LIMITED
  • 483 - 2024-08-13August 13, 2024
  • 483 - 2022-06-23June 23, 2022

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