Uk Mhra Gmp
ALMAC SCIENCES LIMITEDALMAC SCIENCES LIMITED – UK MHRA GMP Certificate UK API 31890 Insp GMP 31890/383321-0022
Record Details
This Uk Mhra Gmp record concerns ALMAC SCIENCES LIMITED, with an inspection on May 7, 2025, issued by the MHRA, covering drugs.
- Company
- ALMAC SCIENCES LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- May 7, 2025
- Issued
- February 11, 2026
- MIA number
- UK API 31890
- Site address
- ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5QD, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000017443] URIDINE TRIACETATE [2000019268] REZAFUNGIN ACETATE [2000018682] AMIFAMPRIDINE PHOSPHATE [3000017276] SELEXIPAG [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES URIDINE TRIACETATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) crystallisation 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing REZAFUNGIN ACETATE 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) purification step using Prep Chromatography 3.1.4 Other Freeze Drying 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Blending 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing AMIFAMPRIDINE PHOSPHATE 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 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing SELEXIPAG 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 micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing ACTIVE SUBSTANCES FOR CLINICAL TRIALS 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, distillation, chromatography or similar alternatives 3.5 General Finishing Steps 3.5.1 Physical Processing Steps micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.5.4 Other Blending & Milling 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing
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ID · ddcd3248-0783-42f3-a820-15179ba61a70
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