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Uk Mhra Gmp
•GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS•January 13, 2025

GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS – UK MHRA GMP Certificate UK API 4 Insp GMP 4/15697-0023

Record Details

This Uk Mhra Gmp record concerns GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, with an inspection on January 13, 2025, issued by the MHRA, covering drugs.

Company
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS
Compliance status
GMPC
Certificate type
GMP
Inspection date
January 13, 2025
Issued
January 23, 2025
MIA number
UK API 4
Site address
NORTH LONSDALE ROAD, ULVERSTON, LA12 9DR, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Medicinal Products
Manufacturing operations
[2000008117] CEFUROXIME AXETIL Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES CEFUROXIME AXETIL 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.4  Other Physical form conversion from crystalline to amorphous form via spray drying 3.5 General Finishing Steps 3.5.1  Physical Processing Steps Spray drying 3.5.2  Primary Packaging 3.5.3  Secondary Packaging 3.6 Quality Control Testing 3.6.1  Physical / Chemical testing
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. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Manufacturing in the Building B12
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ID · 59c6059d-dffc-496f-92ef-18f40aefbe52

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