Uk Mhra Gmp
APTUIT (OXFORD) LIMITEDAPTUIT (OXFORD) LIMITED – UK MHRA GMP Certificate UK API 40699 Insp GMP 40699/7634946-0011
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
- 110-111, 115 E-H, 117 AND 150 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RZ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000002302] FENFLURAMINE [2000006383] FROVATRIPTAN SUCCINATE [1000021934] MAVORIXAFOR [1000015396] PLERIXAFOR Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES FENFLURAMINE 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) Chloride salt formation followed by purification 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 FROVATRIPTAN SUCCINATE 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 formation and crystalisation then drying 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 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) PLERIXAFOR 3.6 Quality Control Testing 3.6.1 Physical / Chemical 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 7634946 also includes authorisation for drug product analysis.
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ID · 86ccd1ca-ec21-45f2-8372-aaec0d04aecf
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