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 10321 |
| 2. Name or corporate name of registrant | RESOLUTION CHEMICALS LIMITED |
| 3. Permanent or legal address of registrant | RESOLUTION CHEMICALS LIMITED, WEDGEWOOD WAY, STEVENAGE, SG1 4QT, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
RESOLUTION CHEMICALS LIMITED, WEDGEWOOD WAY, STEVENAGE, SG1 4QT, 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 | 27/03/2024 |
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
RESOLUTION CHEMICALS LIMITED, WEDGEWOOD WAY, STEVENAGE, SG1 4QT, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| LACTULOSE LIQUID (4000003613) | LACSA (PTY) LIMITED, 72 BALLANTRAE ROAD, MEREBANK, DURBAN, 4052, SOUTH AFRICA |
||
| CYPROTERONE ACETATE (2000007860) | ZHEJIANG XIANJU PHARMACEUTICAL CO., LIMITED, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA |
||
| AZATHIOPRINE (1000009761) | ZHEJIANG CHENG YI PHARMACEUTICAL CO. LIMITED., 118 HUA-GONG ROAD, DONGTOU DISTRICT, WENZHOU, ZHEJIANG PROVINCE, CN 325700, CHINA |
||
| HYDROCORTISONE (1000008762) | TIANJIN JINJIN PHARMACEUTICAL CO., LIMITED SITE B, 8 JINGFU ROAD, ZHANGJIAWO TOWN INDUSTRIAL ZONE, XIQING DISTRICT ECONOMIC AND DEVELOPMENT AREA, ZHANGJIAWO, TIANJIN, CN-300380, CHINA TIANJIN JINJIN PHARMACEUTICAL CO., LIMITED SITE A, SOUTH OF ZHOULI VILLAGE, ZHANGJIAWO TOWN, XIQING DISTRICT, TIANJIN, CN-300380, CHINA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| LATANOPROST (1000003257) | |||
| CABERGOLINE (1000007347) | |||
| FLUPENTIXOL DECANOATE (4000006776) | |||
| RASAGILINE (1000000531) | |||
| CYPROTERONE ACETATE (2000007860) | |||
| AZATHIOPRINE (1000009761) | |||
| HYDROCORTISONE (1000008762) | |||