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 22352
2. Name or corporate name of registrantVERTEX PHARMACEUTICALS (EUROPE) LIMITED
3. Permanent or legal address of registrant VERTEX PHARMACEUTICALS (EUROPE) LIMITED, 86-88 JUBILEE AVENUE, MILTON PARK, MILTON, ABINGDON, OX14 4RW, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, C/O VERTEX PHARMACEUTICALS (EUROPE) LIMITED, LEVEL 9, PADDINGTON CENTRAL, 2 KINGDOM STREET, LONDON, W2 6BD, 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

VERTEX PHARMACEUTICALS (EUROPE) LIMITED, C/O VERTEX PHARMACEUTICALS (EUROPE) LIMITED, LEVEL 9, PADDINGTON CENTRAL, 2 KINGDOM STREET, LONDON, W2 6BD, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
Active Substance 3rd Country Manufacturer 3rd Country Distributor
TEZACAFTOR (1000019934)

SHANGHAI STA PHARMACEUTICAL PRODUCT CO., LIMITED, BUILDING 15, 31 YIWEI ROAD, WAIGAOQIAO FREE TRADE ZONE, SHANGHAI, CN-200131, CHINA

CHANGZHOU SYNTHEALL PHARMACEUTICAL CO., LIMITED, NO. 589 NORTH YULONG ROAD, XINBEI DISTRICT, CHANGZHOU, CN-213127, CHINA

SINGOTA SOLUTIONS, 4320 W. ZENITH DRIVE, BLOOMINGTON, 47404, UNITED STATES

IVACAFTOR (3000016532)

SHANGHAI STA PHARMACEUTICAL PRODUCT CO., LIMITED, BUILDING 15, 31 YIWEI ROAD, WAIGAOQIAO FREE TRADE ZONE, SHANGHAI, CN-200131, CHINA

SHANGHAI SYNTHEALL PHARMACEUTICAL CO., LIMITED, NO. 9 YUEGONG ROAD, JINSHAN DISTRICT, SHANGHAI, CN-201507, CHINA

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
ELEXACAFTOR (1000020769)
LUMACAFTOR (1000017498)
TEZACAFTOR (1000019934)
IVACAFTOR (3000016532)