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 57072
2. Name or corporate name of registrantKYOWA KIRIN INTERNATIONAL UK NEWCO LIMITED
3. Permanent or legal address of registrant KYOWA KIRIN INTERNATIONAL UK NEWCO LIMITED, 3 GALABANK BUSINESS PARK, QUEEN STREET, GALASHIELS, TD1 1QH, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

KYOWA KIRIN INTERNATIONAL UK NEWCO LIMITED, 3 GALABANK BUSINESS PARK, QUEEN STREET, GALASHIELS, TD1 1QH, 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 16/07/2024

 

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

KYOWA KIRIN INTERNATIONAL UK NEWCO LIMITED, 3 GALABANK BUSINESS PARK, QUEEN STREET, GALASHIELS, TD1 1QH, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
GRANISETRON (1000009464)
NALOXEGOL OXALATE (2000016379)