Uk Mhra Gmp
CATALENT MICRON TECHNOLOGIES LIMITEDCATALENT MICRON TECHNOLOGIES LIMITED – UK MHRA GMP Certificate UK API 5451 Insp GMP/IMP 5451/16389-0023
Record Details
This Uk Mhra Gmp record concerns CATALENT MICRON TECHNOLOGIES LIMITED, with an inspection on June 26, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- June 26, 2025
- Issued
- June 26, 2025
- MIA number
- UK API 5451
- Site address
- CROSSWAYS BOULEVARD, CROSSWAYS, DARTFORD, DA2 6QY, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000009286] TRILOSTANE [1000000868] ILOPERIDONE [1000009710] SALICYLIC ACID [3000018209] TAZEMETOSTAT [1000000933] NITISINONE [3000020812] RIMEGEPANT [2000010235] ACLIDINIUM BROMIDE [2000008150] OXYTETRACYCLINE DIHYDRATE [2000008494] LOPERAMIDE HYDROCHLORIDE [2000016108] ESTRADIOL HEMIHYDRATE [2000007742] SALBUTAMOL SULPHATE [1000010236] LENALIDOMIDE [2000009969] PAZOPANIB HYDROCHLORIDE [3000013266] AXITINIB [1000008223] ISOTRETINOIN [1000011644] APIXABAN [1000010690] DASATINIB [1000009303] TRETINOIN [1000001996] FOLIC ACID [4000014056] DOLUTEGRAVIR SODIUM [1000004182] CLIOQUINOL [1000000123] ARIPIPRAZOLE [1000009502] MIFEPRISTONE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES TRILOSTANE 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 ILOPERIDONE 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 SALICYLIC ACID 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 TAZEMETOSTAT 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 NITISINONE 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 RIMEGEPANT 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 ACLIDINIUM BROMIDE 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 OXYTETRACYCLINE DIHYDRATE 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 LOPERAMIDE HYDROCHLORIDE 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 ESTRADIOL HEMIHYDRATE 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 SALBUTAMOL SULPHATE 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 LENALIDOMIDE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing PAZOPANIB HYDROCHLORIDE 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 AXITINIB 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 ISOTRETINOIN 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 APIXABAN 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 DASATINIB 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 TRETINOIN 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FOLIC ACID 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 DOLUTEGRAVIR SODIUM 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 CLIOQUINOL 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 ARIPIPRAZOLE 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 MIFEPRISTONE 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
- 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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