Medicines and Healthcare products Regulatory Agency
REGISTRATION OF MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ACTIVE SUBSTANCES TO BE USED AS STARTING MATERIALS IN MEDICINAL PRODUCTS FOR HUMAN USE
| 1. Registration Number | UK API 30812 |
| 2. Name or corporate name of registrant | CRODA EUROPE LIMITED |
| 3. Permanent or legal address of registrant | CRODA EUROPE LIMITED, COWICK HALL, SNAITH, GOOLE, DN14 9AA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
CRODA EUROPE LIMITED, BARNFIELD ROAD, LEEK, ST13 5QJ, UNITED KINGDOM CRODA EUROPE LIMITED, FOUNDRY LANE, DITTON, WIDNES, WA8 8UB, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 09/08/2024 |
This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in MHRA-GMDP.
The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.
SCOPE OF REGISTRATION
CRODA EUROPE LIMITED, BARNFIELD ROAD, LEEK, ST13 5QJ, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.2 Animal Source Extraction | |
| B.6 Purification of Extracted Substance - ANIMAL | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Distillation, Clay Bleaching, Carbon Treatment, Filtration | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Manufacture of omega-3 ethyl esters is a series of purification steps from Crude or Semi-Refined marine oil | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
esterification, distillation, clathration, clay bleaching, carbon treatment, filtration | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Manufacture of omega-3-acid triglycerides is a series of purification steps from Crude or Semi-Refined Marine Oil | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
esterification, distillation, clathration, glycerolysis, clay bleaching, carbon treatment, filtration | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| TITANIUM DIOXIDE (1000009323) | |||
| FISH OIL, RICH IN OMEGA-3 ACIDS (4000016939) | |||
CRODA EUROPE LIMITED, FOUNDRY LANE, DITTON, WIDNES, WA8 8UB, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.4 Mineral Source Extraction | |
| B.5 Modification of Extracted Substance | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Bead milling and dispersion in oil or water | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.4 Mineral Source Extraction | |
| B.5 Modification of Extracted Substance | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Bead milling and dispersion in oil or water | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |