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 22857 |
| 2. Name or corporate name of registrant | PHARMARON MANUFACTURING SERVICES (UK) LTD |
| 3. Permanent or legal address of registrant | PHARMARON MANUFACTURING SERVICES (UK) LTD, WINDMILL INDUSTRIAL ESTATE, SHOTTON LANE, CRAMLINGTON, NE23 3JL, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
PHARMARON MANUFACTURING SERVICES (UK) LTD, WINDMILL INDUSTRIAL ESTATE, SHOTTON LANE, CRAMLINGTON, NE23 3JL, 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 | 25/04/2023 |
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
PHARMARON MANUFACTURING SERVICES (UK) LTD, WINDMILL INDUSTRIAL ESTATE, SHOTTON LANE, CRAMLINGTON, NE23 3JL, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
Active substance
FLURBIPROFEN SODIUM DIHYDRATE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Dried in Oven | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
OPICAPONE
| 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)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Dried to anhydrous | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
DIPIPANONE HYDROCHLORIDE
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
NITISINONE
| 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)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
CANNABIDIOL
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| B.6 Purification of Extracted Substance - PLANT | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
NALOXONE HYDROCHLORIDE
| 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)
Salt formation and crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
S-(+)-FLURBIPROFEN
| 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)
Crystallisation | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Filtration, distillation, crystallisation and centrifugation | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
Active substance
FLURBIPROFEN
| A | Manufacture of Active Substance by Chemical Synthesis |
| A.1 Manufacture of Active Substance Intermediates | |
| A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Sodium salt neutralised and subsequent base crystallised from petrol | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Dried on filter drier and passed through a mill system | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| FLURBIPROFEN SODIUM DIHYDRATE (4000007377) | |||
| OPICAPONE (3000017734) | |||
| DIPIPANONE HYDROCHLORIDE (2000007755) | |||
| NITISINONE (1000000933) | |||
| CANNABIDIOL (1000000540) | |||
| NALOXONE HYDROCHLORIDE (2000008238) | |||
| S-(+)-FLURBIPROFEN (3000017735) | |||
| FLURBIPROFEN (1000002036) | |||