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 46227 |
| 2. Name or corporate name of registrant | SAFIC-ALCAN UK LIMITED |
| 3. Permanent or legal address of registrant | SAFIC-ALCAN UK LIMITED, 812 BIRCHWOOD BOULEVARD, BIRCHWOOD, WARRINGTON, WA3 7QZ, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
H.W. COATES LIMITED, MIDDLEWICH ROAD INDUSTRIAL ESTATE, BYLEY, MIDDLEWICH, CW10 9NT, UNITED KINGDOM SAFIC-ALCAN UK LIMITED, 812 BIRCHWOOD BOULEVARD, BIRCHWOOD, WARRINGTON, WA3 7QZ, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 26/05/2023 |
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
H.W. COATES LIMITED, MIDDLEWICH ROAD INDUSTRIAL ESTATE, BYLEY, MIDDLEWICH, CW10 9NT, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PVT LIMITED, 28-35 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA, GUJARAT, IN-391 340, INDIA |
||
| GUAIFENESIN (3000005625) | NOURYON FUNCTIONAL CHEMICALS B.V., LISPINWEG 6, HERKENBOSCH, NL-6075 CE, NETHERLANDS |
||
| HYDROQUINONE (1000008752) | EASTMAN CHEMICAL COMPANY, 200 SOUTH WILCOX DRIVE, KINGSPORT, 37660, UNITED STATES |
||
| CYANOCOBALAMIN (4000010977) | HEBEI HUARONG PHARMACEUTICAL CO. LIMITED., 50 NORTH 2ND RING ROAD EAST, CHANGAN QU, SHIJIAZHUANG, HEBEI SHENG, CN-050000, CHINA |
||
| SODIUM FEREDETATE (4000007079) | NOURYON FUNCTIONAL CHEMICALS B.V., LISPINWEG 6, HERKENBOSCH, NL-6075 CE, NETHERLANDS |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PARACETAMOL (1000009609) | |||
| TACROLIMUS (1000002882) | |||
| GUAIFENESIN (3000005625) | |||
| ENROFLOXACIN (1000017859) | |||
| SIMETHICONE (1000009128) | |||
| HYDROQUINONE (1000008752) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| AZITHROMYCIN DIHYDRATE (2000007794) | |||
| TRIMETHOPRIM (1000009283) | |||
| FAMOTIDINE (1000002421) | |||
| CYANOCOBALAMIN (4000010977) | |||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | |||
| SODIUM FEREDETATE (4000007079) | |||
| PRAZIQUANTEL (1000015572) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
SAFIC-ALCAN UK LIMITED, 812 BIRCHWOOD BOULEVARD, BIRCHWOOD, WARRINGTON, WA3 7QZ, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| HYDROQUINONE (1000008752) | EASTMAN CHEMICAL COMPANY, 200 SOUTH WILCOX DRIVE, KINGSPORT, 37660, UNITED STATES |
||
| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PVT LIMITED, PLOT NO 1911, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA |
||
| AZITHROMYCIN DIHYDRATE (2000007794) | ZHEJIANG GUOBANG PHARMACEUTICAL CO. LTD., NO. 6 WEIWU ROAD, HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANGYU, ZHEJIANG, CN-312 369, CHINA |
||
| ENALAPRIL MALEATE (2000007672) | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD., XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
||
| PRAZIQUANTEL (1000015572) | HISUN PHARMACEUTICAL (NANTONG) CO., LTD., NO. 18, 4TH HAIBIN ROAD, RUDONG COASTAL, ECONOMIC DEVELOPMENT ZONE, NANTONG, JIANGSU, CN-226407, CHINA |
||
| CYANOCOBALAMIN (4000010977) | HEBEI HUARONG PHARMACEUTICAL CO. LIMITED., 50 NORTH 2ND RING ROAD EAST, CHANGAN QU, SHIJIAZHUANG, HEBEI SHENG, CN-050000, CHINA |
||
| FAMOTIDINE (1000002421) | ALEMBIC PHARMACEUTICALS LTD, VILLAGE PANELAV, PO TAJPURA, NEAR BASKA, TALUKA HALOL, PANCHMAHAL, GUJARAT, IN-389350, INDIA |
||
| ENROFLOXACIN (1000017859) | ZHEJIANG GUOBANG PHARMACEUTICAL CO. LTD., NO. 6 WEIWU ROAD, HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANGYU, ZHEJIANG, CN-312 369, CHINA |
||
| SODIUM FEREDETATE (4000007079) | NOURYON FUNCTIONAL CHEMICALS B.V., LISPINWEG 6, HERKENBOSCH, NL-6075 CE, NETHERLANDS |
||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD., XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
||
| TRIMETHOPRIM (1000009283) | SHOUGUANG FUKANG PHARMACEUTICAL CO. LTD, NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG, SHANDONG PROVINCE, CN-262700, CHINA |
||
| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PVT LIMITED, 28-35 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA, GUJARAT, IN-391 340, INDIA |
||
| TACROLIMUS (1000002882) | JOYANG LABORATORIES, NO. 9 NORTH HAIDOU ROAD, SHEYANG ECONOMIC DEVELOPMENT ZONE, YANCHENG, JIANGSU PROVINCE, CN 224300, CHINA |
||
| METFORMIN HYDROCHLORIDE (2000008338) | SHOUGUANG FUKANG PHARMACEUTICAL CO. LTD, NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG, SHANDONG PROVINCE, CN-262700, CHINA |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| HYDROQUINONE (1000008752) | |||
| SIMETHICONE (1000009128) | |||
| GUAIFENESIN (3000005625) | |||
| AZITHROMYCIN DIHYDRATE (2000007794) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| PRAZIQUANTEL (1000015572) | |||
| CYANOCOBALAMIN (4000010977) | |||
| FAMOTIDINE (1000002421) | |||
| ENROFLOXACIN (1000017859) | |||
| SODIUM FEREDETATE (4000007079) | |||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | |||
| TRIMETHOPRIM (1000009283) | |||
| PARACETAMOL (1000009609) | |||
| TACROLIMUS (1000002882) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||