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 45423 |
2. Name or corporate name of registrant | GEMAPHARM LIMITED |
3. Permanent or legal address of registrant | GEMAPHARM LIMITED, 10 SAVILLE COURT, SAVILLE PLACE, BRISTOL, BS8 4EJ, UNITED KINGDOM |
4. Address(es) of site(s) where registered activities take place |
GEMAPHARM LIMITED, 5 MERCHANT SQUARE, LONDON, W2 1AY, 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
GEMAPHARM LIMITED, 5 MERCHANT SQUARE, LONDON, W2 1AY, UNITED KINGDOM
2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
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A | Importation | ||
Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
CEFTRIAXONE SODIUM (2000008050) | QILU ANTIBIOTICS PHARMACEUTICAL CO. LIMITED., NO. 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN, SHANDONG PROVINCE, CN-250105, CHINA LIVZON SYNTPHARM COMPANY LIMITED, ZHUHAI FREE TRADE ZONE, ZHUHAI CITY, GUANGDONG PROVINCE, CN 519030, CHINA |
SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU ROAD, HIGH-TECH ZONE, JINAN, CN-250104, CHINA WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA JOC GREAT WALL CORP, 8 LIYUAN SOUTH ROAD, JIANGNING DISTRICT, NANJING, CN-211000, CHINA |
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CEFAZOLIN (3000005158) | HARBIN PHARMACEUTICAL GROUP LIMITED, GENERAL PHARMACEUTICAL FACTORY, NO.109 XUEFU ROAD, HANGING DISTRICT, HARBIN, CN-150086, CHINA QILU ANTIBIOTICS PHARMACEUTICAL CO. LIMITED., NO. 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN, SHANDONG PROVINCE, CN-250105, CHINA NCPC HEBEI HUAMIN PHARMACEUTICAL COMPANY LIMITED, NO. 98 HAINAN ROAD, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI PROVINCE, CN 052165, CHINA |
WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU ROAD, HIGH-TECH ZONE, JINAN, CN-250104, CHINA |
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CEFOTAXIME SODIUM (2000008179) | QILU ANTIBIOTICS (LINYI) PHARMACEUTICAL CO., LIMITED., NORTH OF HUAYAN ROAD (W), DEZHOU ECONOMIC DEVELOPMENT ZONE, LINYI COUNTY, DEZHOU CITY, SHANDONG PROVINCE, CN-251 500, CHINA NCPC HEBEI HUAMIN PHARMACEUTICAL COMPANY LIMITED, NO. 98 HAINAN ROAD, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI PROVINCE, CN 052165, CHINA HARBIN PHARMACEUTICAL GROUP LIMITED, GENERAL PHARMACEUTICAL FACTORY, NO.109 XUEFU ROAD, HANGING DISTRICT, HARBIN, CN-150086, CHINA KYONGBO PHARMACEUTICAL CO., LIMITED., 174 SIROK-RO, ASAN-SI, CHUNGCHEONGNAM-DO, KR-31501, SOUTH KOREA |
WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA SHANDONG ANHONG PHARMACEUTICAL CO., LIMITED, NO. 29 HUAYUAN STREET, LINHI COUNTY, DEZHOU CITY, SHANDONG PROVINCE, CN-251500, CHINA HIGH HOPE INT'L GROUP JIANGSU MEDICINES ? HEALTH PRODUCTS IMP. ? EXP.CORP. LIMITED., NO.91 BAIXIA ROAD, NANJING, CN-210001, CHINA JOC GREAT WALL CORP, 8 LIYUAN SOUTH ROAD, JIANGNING DISTRICT, NANJING, CN-211000, CHINA |
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CEFOXITIN (1000006478) | SHENZHEN SALUBRIS PHARMACEUTICALS COMPANY LIMITED, NO.1 FENGHUANGGANG HUABAO INDUSTRIAL DISTRICT, BASANT DISTRICT, SHENZHEN, CN 518102, CHINA |
WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA |
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CEFEPIME DIHYDROCHLORIDE MIXTURE WITH L-ARGININE (2000017655) | SHENZHEN SALUBRIS PHARMACEUTICALS COMPANY LIMITED, NO.1 FENGHUANGGANG HUABAO INDUSTRIAL DISTRICT, BASANT DISTRICT, SHENZHEN, CN 518102, CHINA QILU ANTIBIOTICS PHARMACEUTICAL CO. LIMITED., NO. 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN, SHANDONG PROVINCE, CN-250105, CHINA |
WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU ROAD, HIGH-TECH ZONE, JINAN, CN-250104, CHINA |
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CEFTAZIDIME PENTAHYDRATE WITH SODIUM CARBONATE FOR INJECTION (2000016869) | QILU ANTIBIOTICS PHARMACEUTICAL CO. LIMITED., NO. 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN, SHANDONG PROVINCE, CN-250105, CHINA HARBIN PHARMACEUTICAL GROUP LIMITED, GENERAL PHARMACEUTICAL FACTORY, NO.109 XUEFU ROAD, HANGING DISTRICT, HARBIN, CN-150086, CHINA |
JOC GREAT WALL CORP, 8 LIYUAN SOUTH ROAD, JIANGNING DISTRICT, NANJING, CN-211000, CHINA WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU ROAD, HIGH-TECH ZONE, JINAN, CN-250104, CHINA |
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CEFUROXIME SODIUM (2000008116) | TITAN PHARMACEUTICAL COMPANY LIMITED (GUANGDONG), GUOJING ROAD, LANTANG TOWN, ZIJIN COUNTY, HEYUAN CITY, GUANGDONG PROVINCE, CN-517 447, CHINA |
SPLENDRIS INTERNATIONAL LIMITED, ROOM 420, 4/F, NAN FUNG COMMERCIAL CENTRE, 19 LAM LOK STREET, KOWLOON BAY, Data Not Available, HONG KONG SAR CHINA |
2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
B | Distribution | ||
CEFTRIAXONE SODIUM (2000008050) | |||
CEFAZOLIN (3000005158) | |||
CEFOTAXIME SODIUM (2000008179) | |||
CEFOXITIN (1000006478) | |||
IVERMECTIN (1000001158) | |||
CEFEPIME DIHYDROCHLORIDE MIXTURE WITH L-ARGININE (2000017655) | |||
CEFTAZIDIME PENTAHYDRATE WITH SODIUM CARBONATE FOR INJECTION (2000016869) | |||
CEFUROXIME SODIUM (2000008116) |