Uk Mhra Gmp
APTUIT (OXFORD) LIMITEDAPTUIT (OXFORD) LIMITED – UK MHRA GMP Certificate UK API 40699 Insp GMP 40699/18353863-0003
Record Details
This Uk Mhra Gmp record concerns APTUIT (OXFORD) LIMITED, with an inspection on January 23, 2025, issued by the MHRA, covering drugs.
- Company
- APTUIT (OXFORD) LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- January 23, 2025
- Issued
- January 23, 2025
- MIA number
- UK API 40699
- Site address
- 115E-115H INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4SA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000021934] MAVORIXAFOR [2000006383] FROVATRIPTAN SUCCINATE [1000002302] FENFLURAMINE [1000015396] PLERIXAFOR Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES 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) FROVATRIPTAN SUCCINATE 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FENFLURAMINE 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing PLERIXAFOR 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.
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ID · 0ebd2cd0-108d-4389-b209-ff8262e6921b
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