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 41200 |
| 2. Name or corporate name of registrant | EUTICALS LIMITED |
| 3. Permanent or legal address of registrant | EUTICALS LIMITED, PRINCE WILLIAM AVENUE, SANDYCROFT, DEESIDE, CH5 2PX, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
EUTICALS LIMITED, PRINCE WILLIAM AVENUE, SANDYCROFT, DEESIDE, CH5 2PX, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 01/08/2014 |
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
Name and address of the site
EUTICALS LIMITED, PRINCE WILLIAM AVENUE, SANDYCROFT, DEESIDE, CH5 2PX, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
Active substance
ETHYL SALICYLATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
PURIFICATION BY VACUUM DISTILLATION | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
ISOSORBIDE-5-MONONITRATE DILUTED
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
ADDITIONAL INFO | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
.BLENDING, SIFTING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
PURE ISOSORBIDE-5-MONONITRATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
RECRYSTALLISED FROM AQUEOUS MEDIUM | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
DRYING,SIEVING,BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
ISOSORBIDE DINITRATE DILUTED
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
RECRYSTALLISED FROM MIXED ORGANIC SOLVENT/AQUEOUS MEDIUM | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
DRYING, SIFTING, BLENDING WITH EXCIPIENTS | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
FLUCYTOSINE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
RECRYSTALLISATION FROM AQUEOUS MEDIUM | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
DRYING, SIEVING AND BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
TETRAHYDROFURFURYL SALICYLATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
PURIFICATION BY VACUUM DISTILLATION | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
DIETHYLAMINE SALICYLATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
CRYSTALLISATION FROM NON-AQUEOUS MEDIUM | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
DRYING, MILLING (DE-LUMPING), BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
CARBIMAZOLE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Product crystallised from reaction mix by watering out. Product water washed. | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
HYDROXYETHYL SALICYLATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.2 Manufacture of Crude Active Substance | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
PURIFICATION BY VACUUM DISTILLATION | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
BLENDING | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| ETHYL SALICYLATE (1000002536) | |||
| ISOSORBIDE-5-MONONITRATE DILUTED (4000007687) | |||
| PURE ISOSORBIDE-5-MONONITRATE (4000012894) | |||
| SALICYLIC ACID (1000009710) | |||
| ISOSORBIDE DINITRATE DILUTED (4000009827) | |||
| FLUCYTOSINE (1000002211) | |||
| TETRAHYDROFURFURYL SALICYLATE (4000006661) | |||
| DIETHYLAMINE SALICYLATE (2000007771) | |||
| CARBIMAZOLE (1000006699) | |||
| HYDROXYETHYL SALICYLATE (3000003723) | |||