Uk Mhra Gmp
BASF PHARMA (CALLANISH) LIMITEDBASF PHARMA (CALLANISH) LIMITED – UK MHRA GMP Certificate UK API 33889 Insp GMP 33889/596852-0008
Record Details
This Uk Mhra Gmp record concerns BASF PHARMA (CALLANISH) LIMITED, with an inspection on December 9, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 9, 2025
- Issued
- December 9, 2025
- MIA number
- UK API 33889
- Site address
- BREASCLETE, CALLANISH, ISLE OF LEWIS, HS2 9ED, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000002806] EICOSAPENTAENOIC ACID [1000002929] DOCOSAHEXAENOIC ACID Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES EICOSAPENTAENOIC ACID 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) SMB Purification / Flash refining 3.5 General Finishing Steps 3.5.1 Physical Processing Steps final refining & purification 3.5.2 Primary Packaging Other : Material is sensitive to oxidation, must be kept under a gas blanket of oxygen free nitrogen. 3.5.3 Secondary Packaging Other : Material is sensitive to oxidation, must be kept under a gas blanket of oxygen free nitrogen. 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) DOCOSAHEXAENOIC ACID 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) SMB purification / Flash Refining 3.5 General Finishing Steps 3.5.1 Physical Processing Steps SMB Refining Purification 3.5.2 Primary Packaging Other : Material sensitive to oxidation must be strored under nitrogen blanket 3.5.3 Secondary Packaging Other : Material sensitive to oxidation must be strored under nitrogen blanket 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) 3.6.3 Microbiological testing (including 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 · a61f7254-73f8-4a9f-9001-e1f8ee0eb417
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