Uk Mhra Gmp
HVL PHARMA UK LTDHVL PHARMA UK LTD – UK MHRA GMP Certificate UK API 8596 Insp GMP/IMP 8596/18052-0037
Record Details
This Uk Mhra Gmp record concerns HVL PHARMA UK LTD, with an inspection on October 1, 2025, issued by the MHRA, covering drugs.
- Company
- HVL PHARMA UK LTD
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- October 1, 2025
- Issued
- November 3, 2025
- MIA number
- UK API 8596
- Site address
- 37 HOLLANDS ROAD, HAVERHILL, CB9 8PU, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000014239] SEVELAMER CARBONATE [2000009246] SEVELAMER HYDROCHLORIDE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES SEVELAMER CARBONATE 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) Extraction, washing and salt conversion 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling and sieving 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) SEVELAMER 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) Extraction, washing and salt conversion 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling and sieving 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)
- 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 · 27f0d3e9-1da3-4927-afb8-d55dfe93e4e9
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