Uk Mhra Gmp
APTUIT (OXFORD) LIMITEDAPTUIT (OXFORD) LIMITED – UK MHRA GMP Certificate UK API 40699 Insp GMP 40699/839548-0009
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
- 150 BROOK DRIVE, MILTON PARK, ABINGDON, OX14 4SD, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000006383] FROVATRIPTAN SUCCINATE [1000002302] FENFLURAMINE [1000015396] PLERIXAFOR Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES 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 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 PLERIXAFOR 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) FINAL STEP INVOLVES CRYSTALLISATION 3.5 General Finishing Steps 3.5.1 Physical Processing Steps MANUFACTURE INVOLVES DRYING 3.5.2 Primary Packaging 3.5.3 Secondary Packaging
- 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 · f8a4816d-1ee9-4b01-9388-ded78e46fa9b
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