Uk Mhra Gmp
FINE ORGANICS LIMITEDFINE ORGANICS LIMITED – UK MHRA GMP Certificate UK API 5965 Insp GMP 5965/16804-0006 [H]
Record Details
This Uk Mhra Gmp record concerns FINE ORGANICS LIMITED, with an inspection on January 7, 2026, issued by the MHRA, covering drugs.
- Company
- FINE ORGANICS LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- January 7, 2026
- Issued
- January 7, 2026
- MIA number
- UK API 5965
- Site address
- SEAL SANDS, MIDDLESBROUGH, TS2 1UB, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000017828] CLORSULON [1000022037] FLUAZURON [2000017117] METARAMINOL BITARTRATE [1000022773] 4-CYANO-3-(TRIFLUOROMETHYL)PHENYLISOTHIOCYANATE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES CLORSULON 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 3.6.2 Microbiological testing (excluding sterility testing) FLUAZURON 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 3.6.2 Microbiological testing (excluding sterility testing) METARAMINOL BITARTRATE 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 4-CYANO-3-(TRIFLUOROMETHYL)PHENYLISOTHIOCYANATE 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
- 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. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Manufacture is authorised in production Workshop 1 (north) and Workshop 4 only. The scope of the certificate includes the manufacture of APIs and intermediates for use in human and veterinary medicinal products.
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ID · e52238c0-dbf2-4ac2-9b5a-bf788c76da11
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