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 4543 |
| 2. Name or corporate name of registrant | CP PHARMACEUTICALS LIMITED |
| 3. Permanent or legal address of registrant | CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, 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 | 07/06/2024 |
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
CP PHARMACEUTICALS LIMITED, ASH ROAD NORTH, WREXHAM, LL13 9UF, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CHLORPHENAMINE MALEATE (4000007290) | SUPRIYA LIFESCIENCE LIMITED, A-5/2 LOTE PARSHURAM INDUSTRIAL AREA, MIDC, TALUKA KHED, RATNAGIRI, MAHARASHTRA, IN-415 722, INDIA |
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| SODIUM VALPROATE (2000007475) | SCI PHARMTECH INCORPORATED, NO. 61, LN. 309, HAIHU NORTH ROAD, LUZHU DISTRICT, TAOYUAN, TW-33856, TAIWAN |
||
| HEPARIN SODIUM PORCINE (4000015595) | SMITHFIELD BIOSCIENCE, 12150 BEST PLACE, CINCINNATI, 45241-1569, UNITED STATES SHENZHEN HEPALINK PHARMACEUTICAL CO., LIMITED, 21 LANGSHAN ROAD, SONGPINGSHAN, NANSHAN DISTRICT, SHENZHEN, GUANGDONG PROVINCE, CN-518 057, CHINA |
||
| ADENOSINE (1000009941) | WOCKHARDT LIMITED, PLOT NO. 138, GIDC ESTATE, ANKLESHWAR, DISTRICT BHARUCH, GUJARAT, IN 393002, INDIA |
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| HYALURONIDASE (1000008783) | BBI ENZYMES SA (PTY) LIMITED, 19 PACKER AVENUE, EPPING 2, EPPINDUST, CAPE TOWN, ZA-7475, SOUTH AFRICA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CHLORPHENAMINE MALEATE (4000007290) | |||
| SODIUM VALPROATE (2000007475) | |||
| HEPARIN SODIUM PORCINE (4000015595) | |||
| MILRINONE (1000009496) | |||
| PROTAMINE SULFATE (2000012754) | |||
| LEVOMEPROMAZINE (1000013818) | |||
| HEPARIN SODIUM BOVINE (4000013957) | |||