Uk Mhra Gmp
INDIVIOR UK LIMITEDINDIVIOR UK LIMITED – UK MHRA GMP Certificate UK API 36699 Insp GMP 36699/17092-0056
Record Details
This Uk Mhra Gmp record concerns INDIVIOR UK LIMITED, with an inspection on May 22, 2025, issued by the MHRA, covering drugs.
- Company
- INDIVIOR UK LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- May 22, 2025
- Issued
- May 22, 2025
- MIA number
- UK API 36699
- Site address
- DANSOM LANE, HULL, HU8 7DS, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000008277] BUPRENORPHINE HYDROCHLORIDE [1000007171] BUPRENORPHINE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES BUPRENORPHINE 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) API is precipitated by formation of hydrochloride salt using hydrogen chloride gas 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Product is dried under nitrogen / vacuum and then sieved 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing BUPRENORPHINE 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 & filtration of Stage 6R material 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
- 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 · 19439500-fc01-4397-bcd7-ecf4e2fc9efb
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