Uk Mhra Gmp
APTUIT (OXFORD) LIMITEDAPTUIT (OXFORD) LIMITED – UK MHRA GMP Certificate UK API 40699 Insp GMP 40699/18353863-0005
Record Details
This Uk Mhra Gmp record concerns APTUIT (OXFORD) LIMITED, with an inspection on February 24, 2026, issued by the MHRA, covering drugs.
- Company
- APTUIT (OXFORD) LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- February 24, 2026
- Issued
- April 20, 2026
- MIA number
- UK API 40699
- Site address
- 115E-115H OLYMPIC AVENUE, MILTON PARK, MILTON, ABINGDON, OX14 4SA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000002302] FENFLURAMINE [2000006383] FROVATRIPTAN SUCCINATE [1000015396] PLERIXAFOR [1000021934] MAVORIXAFOR Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES FENFLURAMINE 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FROVATRIPTAN SUCCINATE 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing PLERIXAFOR 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing MAVORIXAFOR 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Salt release followed by crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products In addition to API QC analysis, the GMP certificate for site number 18353863 also includes authorisation for drug product analysis.
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ID · f5e3380d-b236-4fd3-9c94-93c9d5de7f08
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