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 61246 |
| 2. Name or corporate name of registrant | ASYMCHEM LIMITED |
| 3. Permanent or legal address of registrant | ASYMCHEM LIMITED, BUILDING 530, DISCOVERY PARK HOUSE, DISCOVERY PARK, RAMSGATE ROAD, SANDWICH, CT13 9ND, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ASYMCHEM LIMITED, BUILDING 530, DISCOVERY PARK HOUSE, DISCOVERY PARK, RAMSGATE ROAD, SANDWICH, CT13 9ND, 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 | 27/11/2025 |
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
ASYMCHEM LIMITED, BUILDING 530, DISCOVERY PARK HOUSE, DISCOVERY PARK, RAMSGATE ROAD, SANDWICH, CT13 9ND, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| 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, recrystallisation, filtration, salt formation and Chromatography | |
| A.4 Other
polymorph transformation, particle size reduction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying, Particle size reduction | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |