Medicines and Healthcare products Regulatory Agency
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The competent authority of United Kingdom confirms the following :Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 19/03/2025, it is considered that it complies with
- The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.
- (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
- (2) These requirements fulfil the GMP recommendations of WHO.
Manufacture of active substance. Names of substances subject to inspection:
- [2000019379] EP0042 FUMARATE
- [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS
- [3000024079] EDV2209
| 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES | |
| EP0042 FUMARATE | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) The multistep synthesis of EP0042 included recrystallisation of the free base and formation of the fumarate salt | |
| 3.5 | General Finishing Steps |
| 3.5.2 Primary Packaging | |
| 3.5.3 Secondary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ACTIVE SUBSTANCES FOR CLINICAL TRIALS | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Purifcation by recrystallisation and salt formation | |
| 3.5 | General Finishing Steps |
| 3.5.2 Primary Packaging | |
| 3.5.3 Secondary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| EDV2209 | |
| 3.1 | Manufacture of Active Substance by Chemical Synthesis |
| 3.1.1 Manufacture Of Active Substance Intermediates | |
| 3.1.2 Manufacture Of Crude Active Substance | |
| 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Purification by recrystallisation | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
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.
Any restrictions related to the scope of this certificate:
| Building | Room | Line/equipment | QC Testing | Products |
|---|---|---|---|---|
| This certificate is valid for the manufacture of APIs for use in clinical trials only. |
| 19/03/2025 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |