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

Registrant Details
1. Registration NumberUK API 43235
2. Name or corporate name of registrantKD PHARMA UK LIMITED
3. Permanent or legal address of registrant KD PHARMA UK LIMITED, SEAL SANDS, MIDDLESBROUGH, TS2 1UB, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

KD PHARMA UK LIMITED, SEAL SANDS, MIDDLESBROUGH, TS2 1UB, UNITED KINGDOM

5. National legal basis of registration
6. Name of responsible officer of the competent authority of the member state validating the registration Confidential
7. Date 10/05/2024

 

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

Name and address of the site

KD PHARMA UK LIMITED, SEAL SANDS, MIDDLESBROUGH, TS2 1UB, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
OMEGA-3-ACID ETHYL ESTERS
2000009912
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
E General Finishing Steps
E.1 Physical Processing Steps
Separation of fatty acid ethyl esters
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
OMEGA-3-ACID ETHYL ESTERS (2000009912)