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 |
SAFIC-ALCAN UK LIMITED, 812 BIRCHWOOD BOULEVARD, BIRCHWOOD, WARRINGTON, WA3 7QZ, UNITED KINGDOM H.W. COATES LIMITED, MIDDLEWICH ROAD INDUSTRIAL ESTATE, BYLEY, MIDDLEWICH, CW10 9NT, 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 | 04/07/2024 |
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
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 | |
| NEOMYCIN SULPHATE (2000008175) | YICHANG SANXIA PHARMACEUTICAL COMPANY LIMITED, NO. 8 ZIYANG ROAD, DIAJUN DISTRICT, YICHANG, HUBEI, CN-443002, CHINA |
||
| PRAZIQUANTEL (1000015572) | HISUN PHARMACEUTICAL (NANTONG) CO., LTD., NO. 18, 4TH HAIBIN ROAD, RUDONG COASTAL, ECONOMIC DEVELOPMENT ZONE, NANTONG, JIANGSU, CN-226407, CHINA |
||
| N-ACETYLCYSTEINE (3000005344) | WUHAN GRAND HOYO COMPANY LIMITED, ROOM 1, 6TH FLOOR, BUILDING 3, INTERNATIONAL ENTERPRISE CENTRE, NO. T1, GUANSHAN 2ND ROAD, EAST LAKE HIGH TECH DEVELOPMENT ZONE, WUHAN, HUBEI PROVINCE, CN-430070, CHINA |
||
| SODIUM FEREDETATE (4000007079) | NOURYON FUNCTIONAL CHEMICALS B.V., LISPINWEG 6, HERKENBOSCH, NL-6075 CE, NETHERLANDS |
||
| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PVT LIMITED, PLOT NO 1911, B-5, INDUSTRIAL ESTATE, SANATHNAGAR, HYDERABAD, IN-500 018, INDIA |
||
| TACROLIMUS (1000002882) | JOYANG LABORATORIES, NO. 9 NORTH HAIDOU ROAD, SHEYANG ECONOMIC DEVELOPMENT ZONE, YANCHENG, JIANGSU PROVINCE, CN 224300, CHINA |
||
| HYDROQUINONE (1000008752) | EASTMAN CHEMICAL COMPANY, 200 SOUTH WILCOX DRIVE, KINGSPORT, 37660, UNITED STATES |
||
| DEXAMETHASONE (1000003334) | TIANJIN TIANYAO PHARMACEUTICALS CO LIMITED, 19 XINYE 9TH STREET, WEST AREA OF TEDA, TIANJIN, CN-300 462, CHINA |
||
| FAMOTIDINE (1000002421) | ALEMBIC PHARMACEUTICALS LTD, VILLAGE PANELAV, PO TAJPURA, NEAR BASKA, TALUKA HALOL, PANCHMAHAL, GUJARAT, IN-389350, INDIA |
||
| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PVT LIMITED, PLOT NO. 28-35 G.I.D.C. INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
||
| METRONIDAZOLE BENZOATE (2000008258) | HUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LIMITED., NO. 8, HONGYUAN ROAD, ECONOMIC DEVELOPMENT ZONE, LUOTIAN COUNTY, FENGSHAN TOWN, HUANGGANG CITY, HUBEI, CN-438 600, CHINA |
||
| 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 |
||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD., XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
||
| ENALAPRIL MALEATE (2000007672) | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD., XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
||
| METFORMIN HYDROCHLORIDE (2000008338) | SHOUGUANG FUKANG PHARMACEUTICAL CO. LTD, NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG, SHANDONG PROVINCE, CN-262700, CHINA |
||
| CYANOCOBALAMIN (4000010977) | HEBEI HUARONG PHARMACEUTICAL CO. LIMITED., 50 NORTH 2ND RING ROAD EAST, CHANGAN QU, SHIJIAZHUANG, HEBEI SHENG, CN-050000, CHINA |
||
| DOXYCYCLINE MONOHYDRATE (2000007682) | YANCHENG SUHAI PHARMACEUTICALS COMPANY LIMITED, HUAFENG INDUSTRIAL PARK, DAFENG PORT ECONOMIC ZONE, DAFENG DISTRICT, YANCHENG CITY, JIANGSU PROVINCE, CN-224100, CHINA |
||
| PREDNISOLONE ACETATE (2000007916) | ZHEJIANG XIANJU PHARMACEUTICAL CO. LIMITED, NO. 1 XIANYAO ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA |
||
| 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 |
||
| SUCRALFATE (1000009411) | ZHEJIANG HAISEN PHARMACEUTICAL CO., LIMITED., LIUSHI STREET, DONGYANG CITY, ZHEJIANG, CN-322104, CHINA |
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| TRIMETHOPRIM (1000009283) | 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 | ||
| NEOMYCIN SULPHATE (2000008175) | |||
| PRAZIQUANTEL (1000015572) | |||
| N-ACETYLCYSTEINE (3000005344) | |||
| SODIUM FEREDETATE (4000007079) | |||
| GUAIFENESIN (3000005625) | |||
| TACROLIMUS (1000002882) | |||
| HYDROQUINONE (1000008752) | |||
| DEXAMETHASONE (1000003334) | |||
| SIMETHICONE (1000009128) | |||
| FAMOTIDINE (1000002421) | |||
| PARACETAMOL (1000009609) | |||
| METRONIDAZOLE BENZOATE (2000008258) | |||
| ENROFLOXACIN (1000017859) | |||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| CYANOCOBALAMIN (4000010977) | |||
| DOXYCYCLINE MONOHYDRATE (2000007682) | |||
| PREDNISOLONE ACETATE (2000007916) | |||
| AZITHROMYCIN DIHYDRATE (2000007794) | |||
| SUCRALFATE (1000009411) | |||
| TRIMETHOPRIM (1000009283) | |||
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 | |
| 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 |
||
| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PVT LIMITED, PLOT NO. 28-35 G.I.D.C. INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
||
| 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 | ||
| GUAIFENESIN (3000005625) | |||
| SUCRALFATE (1000009411) | |||
| METRONIDAZOLE BENZOATE (2000008258) | |||
| HYDROQUINONE (1000008752) | |||
| DEXAMETHASONE (1000003334) | |||
| PARACETAMOL (1000009609) | |||
| TRIMETHOPRIM (1000009283) | |||
| ENROFLOXACIN (1000017859) | |||
| NEOMYCIN SULPHATE (2000008175) | |||
| CYANOCOBALAMIN (4000010977) | |||
| ENALAPRIL MALEATE (2000007672) | |||
| DOXYCYCLINE MONOHYDRATE (2000007682) | |||
| PREDNISOLONE ACETATE (2000007916) | |||
| FAMOTIDINE (1000002421) | |||
| AZITHROMYCIN DIHYDRATE (2000007794) | |||
| PRAZIQUANTEL (1000015572) | |||
| SODIUM FEREDETATE (4000007079) | |||
| N-ACETYLCYSTEINE (3000005344) | |||
| BENAZEPRIL HYDROCHLORIDE (2000006111) | |||
| TACROLIMUS (1000002882) | |||
| METFORMIN HYDROCHLORIDE (2000008338) | |||
| SIMETHICONE (1000009128) | |||