Uk Mhra Gmp
PHARMARON MANUFACTURING SERVICES (UK) LTDPHARMARON MANUFACTURING SERVICES (UK) LTD – UK MHRA GMP Certificate UK API 22857 Insp GMP 22857/36790-0009
Record Details
This Uk Mhra Gmp record concerns PHARMARON MANUFACTURING SERVICES (UK) LTD, with an inspection on March 24, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- March 24, 2025
- Issued
- March 24, 2025
- MIA number
- UK API 22857
- Site address
- WINDMILL INDUSTRIAL ESTATE, SHOTTON LANE, CRAMLINGTON, NE23 3JL, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000000540] CANNABIDIOL [1000020451] ACOZIBOROLE [2000008238] NALOXONE HYDROCHLORIDE [3000017735] S-(+)-FLURBIPROFEN [1000000933] NITISINONE [4000007377] FLURBIPROFEN SODIUM DIHYDRATE [2000007755] DIPIPANONE HYDROCHLORIDE [1000000208] NALTREXONE [1000002036] FLURBIPROFEN Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES CANNABIDIOL 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.2.6 Purification of extracted substance 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 ACOZIBOROLE 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) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Filtration and drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing NALOXONE HYDROCHLORIDE 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 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 S-(+)-FLURBIPROFEN 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) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Filtration, distillation, crystallisation and centrifugation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing NITISINONE 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) 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 FLURBIPROFEN SODIUM DIHYDRATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Salt formation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Dried in Oven 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing DIPIPANONE HYDROCHLORIDE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) 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 NALTREXONE 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 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FLURBIPROFEN 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Sodium salt neutralised and subsequent base crystallised from petrol 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Dried on filter drier and passed through a mill system 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.
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ID · 939ce2fe-2eb8-498e-a20a-ae95b827eb6a
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