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Medicines and Healthcare Products Regulatory Agency 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 Registrant Details 1. Registration Number UK API 45423 2. Name or corporate name of registrant GEMAPHARM LIMITED GEMAPHARM LIMITED, 10 SAVILLE COURT, SAVILLE PLACE, 3. Permanent or legal address of registrant BRISTOL, BS8 4EJ, UNITED KINGDOM GEMAPHARM LIMITED, 2 EASTBOURNE TERRACE, LONDON, 4. Address(es) of site(s) where registered activities take place W2 6LG, UNITED KINGDOM Regulation 327 of The Human Medicines Regulations 2012 (SI 5. National legal basis of registration 2012/1916) 6. Name of responsible officer of the competent authority of the Confidential member state validating the registration 7. Date 28/07/2021 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 Name and address of the site GEMAPHARM LIMITED, 2 EASTBOURNE TERRACE, LONDON, W2 6LG, UNITED KINGDOM 2. IMPORTATION AND DISTRIBUTION OPERATIONS A Importation Active Substance 3rd Country Manufacturer 3rd Country Distributor Page 1 of 4 API Registration Number: UK API 45423 Issue Date: 28 Jul 2021 WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG QILU ANTIBIOTICS PHARMACEUTICAL CO. KONG, Data Not Available, CHINA LIMITED., 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN CITY, SHANDONG SHANDONG QILU MEDICINES IMPORT CEFTRIAXONE SODIUM PROVINCE, CN-250105, CHINA & EXPORT CO., LIMITED, 8888 LVYOU (2000008050) ROAD, HIGH-TECH ZONE, JINAN, CN- LIVZON SYNTPHARM COMPANY LIMITED, 250104, CHINA ZHUHAI FREE TRADE ZONE, ZHUHAI CITY, GUANGDONG PROVINCE, CN 519030, CHINA JOC GREAT WALL CORP, 8 LIYUAN SOUTH ROAD, JIANGNING DISTRICT, NANJING, CN-211000, CHINA SHENZHEN SALUBRIS PHARMACEUTICALS WINCOMFORT-ALLCHIM LIMITED, UNIT COMPANY LIMITED, NO.1 FENGHUANGGANG G, 12/F SEABRIGHT PLAZA, NO. 9-23 CEFOXITIN (1000006478) HUABAO INDUSTRIAL DISTRICT, BASANT SHELL STREET, NORTH POINT, HONG DISTRICT, SHENZHEN, CN 518102, CHINA KONG, Data Not Available, CHINA TITAN PHARMACEUTICAL COMPANY SPLENDRIS INTERNATIONAL LIMITED, LIMITED (GUANGDONG), GUOJING ROAD, ROOM 420, 4/F, NAN FUNG CEFUROXIME SODIUM LANTANG TOWN, ZIJIN COUNTY, HEYUAN COMMERCIAL CENTRE, 19 LAM LOK (2000008116) CITY, GUANGDONG PROVINCE, CN-517 447, STREET, KOWLOON BAY, Data Not CHINA Available, HONG KONG SAR CHINA CEFEPIME SHENZHEN SALUBRIS PHARMACEUTICALS WINCOMFORT-ALLCHIM LIMITED, UNIT DIHYDROCHLORIDE MIXTURE COMPANY LIMITED, NO.1 FENGHUANGGANG G, 12/F SEABRIGHT PLAZA, NO. 9-23 WITH L-ARGININE HUABAO INDUSTRIAL DISTRICT, BASANT SHELL STREET, NORTH POINT, HONG (2000017655) DISTRICT, SHENZHEN, CN 518102, CHINA KONG, Data Not Available, CHINA SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU QILU ANTIBIOTICS PHARMACEUTICAL CO. ROAD, HIGH-TECH ZONE, JINAN, CN- LIMITED., 849 DONGJIA TOWN, LICHENG 250104, CHINA DISTRICT, JINAN CITY, SHANDONG CEFTAZIDIME PROVINCE, CN-250105, CHINA JOC GREAT WALL CORP, 8 LIYUAN PENTAHYDRATE WITH SOUTH ROAD, JIANGNING DISTRICT, SODIUM CARBONATE FOR HARBIN PHARMACEUTICAL GROUP LIMITED, NANJING, CN-211000, CHINA INJECTION (2000016869) GENERAL PHARMACEUTICAL FACTORY, NO.109 XUEFU ROAD, HANGING DISTRICT, WINCOMFORT-ALLCHIM LIMITED, UNIT HARBIN, CN-150086, CHINA G, 12/F SEABRIGHT PLAZA, NO. 9-23 SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA Page 2 of 4 API Registration Number: UK API 45423 Issue Date: 28 Jul 2021 QILU ANTIBIOTICS PHARMACEUTICAL CO. LIMITED., 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN CITY, SHANDONG PROVINCE, CN-250105, CHINA WINCOMFORT-ALLCHIM LIMITED, UNIT G, 12/F SEABRIGHT PLAZA, NO. 9-23 HARBIN PHARMACEUTICAL GROUP LIMITED, SHELL STREET, NORTH POINT, HONG GENERAL PHARMACEUTICAL FACTORY, KONG, Data Not Available, CHINA CEFAZOLIN (3000005158) NO.109 XUEFU ROAD, HANGING DISTRICT, HARBIN, CN-150086, CHINA SHANDONG QILU MEDICINES IMPORT & EXPORT CO., LIMITED, 8888 LVYOU NCPC HEBEI HUAMIN PHARMACEUTICAL ROAD, HIGH-TECH ZONE, JINAN, CN- COMPANY LIMITED, NO. 98 HAINAN ROAD, 250104, CHINA ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI PROVINCE, CN 052165, CHINA KYONGBO PHARMACEUTICAL CO., LIMITED., 174 SIROK-RO, ASAN-SI, HIGH HOPE INT'L GROUP JIANGSU CHUNGCHEONGNAM-DO, KR-31501, SOUTH MEDICINES ? HEALTH PRODUCTS IMP. KOREA ? EXP.CORP. LIMITED., NO.91 BAIXIA ROAD, NANJING, CN-210001, CHINA HARBIN PHARMACEUTICAL GROUP LIMITED, GENERAL PHARMACEUTICAL FACTORY, WINCOMFORT-ALLCHIM LIMITED, UNIT NO.109 XUEFU ROAD, HANGING DISTRICT, G, 12/F SEABRIGHT PLAZA, NO. 9-23 HARBIN, CN-150086, CHINA SHELL STREET, NORTH POINT, HONG KONG, Data Not Available, CHINA CEFOTAXIME SODIUM QILU ANTIBIOTICS (LINYI) (2000008179) PHARMACEUTICAL CO., LIMITED., NORTH OF SHANDONG ANHONG HUAYAN ROAD (W), DEZHOU ECONOMIC PHARMACEUTICAL CO., LIMITED, NO. DEVELOPMENT ZONE, LINYI COUNTY, 29 HUAYUAN STREET, LINHI COUNTY, DEZHOU CITY, SHANDONG PROVINCE, CN- DEZHOU CITY, SHANDONG PROVINCE, 251 500, CHINA CN-251500, CHINA NCPC HEBEI HUAMIN PHARMACEUTICAL JOC GREAT WALL CORP, 8 LIYUAN COMPANY LIMITED, NO. 98 HAINAN ROAD, SOUTH ROAD, JIANGNING DISTRICT, ECONOMIC AND TECHNOLOGICAL NANJING, CN-211000, CHINA DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI PROVINCE, CN 052165, CHINA 2. IMPORTATION AND DISTRIBUTION OPERATIONS B Distribution CEFTRIAXONE SODIUM (2000008050) IVERMECTIN (1000001158) CEFOXITIN (1000006478) CEFUROXIME SODIUM (2000008116) CEFEPIME DIHYDROCHLORIDE MIXTURE WITH L-ARGININE (2000017655) CEFTAZIDIME PENTAHYDRATE WITH SODIUM CARBONATE FOR INJECTION (2000016869) Page 3 of 4 API Registration Number: UK API 45423 Issue Date: 28 Jul 2021 CEFAZOLIN (3000005158) CEFOTAXIME SODIUM (2000008179) Page 4 of 4 API Registration Number: UK API 45423 Issue Date: 28 Jul 2021.
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