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 119 |
| 2. Name or corporate name of registrant | ANDARD-MOUNT COMPANY LIMITED |
| 3. Permanent or legal address of registrant | ANDARD-MOUNT COMPANY LIMITED, WEST AFRICA HOUSE, ASHBOURNE ROAD, EALING, W5 3QP, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ANDARD-MOUNT COMPANY LIMITED, 20 HANOVER SQUARE, LONDON, W1S 1JY, 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 | 09/01/2015 |
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
ANDARD-MOUNT COMPANY LIMITED, 20 HANOVER SQUARE, LONDON, W1S 1JY, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CARBOPLATIN (1000006649) | HANDE INDUSTRY & TRADE HOLDINGS LIMITED, ROOM 2313-2316, HUANGDU PLAZA, 3008 YITIAN ROAD, SHENZHEN, CN 518048, CHINA SUN PHARMACEUTICAL INDUSTRIES LIMITED, ACME PLAZA, ANDHERI-KURLA ROAD, ANDHERI (EAST), MUMBAI, IN-400 059, INDIA LIANYUNGANG GUI YUAN CHEMPHARM, C24 ORIENTAL GARDEN, XINPU, LIANYUNGANG, JIANGSU, CN-222006, CHINA |
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| METHOXSALEN (1000007442) | KUMAON CHEMICAL PRODUCTS, SHIVLALPUR, DISTRICT NAINITAL, RAMNAGAR, UTTARANCHAL, IN-244175, INDIA HINDUSTAN PHARMACEUTICALS PRIVATE LIMITED, KOT MIT SINGH, TARN TARAN ROAD, AMRITSAR, PUNJAB, IN 143002, INDIA INDO WORLD TRADING CORPORATION, B-11/6 MOHAN CO-OPERATIVE INDUSTRIAL ESATE, BADARPUR, NEW DELHI, IN-110 044, INDIA |
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| HEPARIN SODIUM (2000007631) | YANTAI DONGCHENG BIOCHEMICALS LIMITED, NO. 7 CHANGBAISHAN ROAD, YANTAI DEVELOPMENT ZONE, SHANDONG PROVINCE, CN-264006, CHINA SHANDONG TOPSCIENCE BIO-TECH COMPANY LIMITED, C/O QINGDAO LONGBIDELLY TRADING,, NO. 467 HANGZHOU ROAD, JIAZHOU CITY, QINGDAO, CN-266100, CHINA JIANGSU SAINTEK COMPANY LIMITED, 5TH FLOOR, 327 WEST TONGFENG ROAD, KUNSHAN, JIANGSU, CN 215300, CHINA |
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| CLOMIPHENE CITRATE (4000015107) | AR-EX LABORATORIES PRIVATE LIMITED, 21 SITALADEVI TEMPLE ROAD, MAHIM, MUMBAI, IN-400 016, INDIA ALIGNS INTERNATIONAL, 320/322 SARDAR GRIHA BUILDING, 198 LT MARG, CRAWFORD MARKET, MUMBAI, IN-400001, INDIA SHENZHEN BODA BIOPHARM COMPANY LIMITED, ROOM 1605, SICHUAN BUILDING, FUTIAN DISTRICT, HONGLI ROAD, SHENZHEN, CN-518028, CHINA |
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| PROGESTERONE (1000009777) | TAIZHOU TAIFA PHARMACEUTICALS COMPANY LIMITED , NO. 14 INDUSTRIAL EAST ROAD, XIANJU, ZHEJIANG, CN-317300, CHINA XIAMEN KING-WAYS CHEMICAL COMPANY LIMITED, 24 SUJIAFENG, HAIDIAN DISTRICT, BEIJING, CN-100082, CHINA TIANJIN TIANMAO TECHNOLOGY DEVELOPMENT CORPORATION LIMITED, HI-TECH BUILDING A, ROOM 507-511, HUATIAN ROAD, HUAYUAN INDUSTRY PARK, TIANJIN, CN-300384, CHINA |
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| RUM POWDER (2000016905) | SATO FOOD INDUSTRIES, 4-154 HORINOUCHI, KOMAKI CITY, AICHI, JP-485-8523, JAPAN |
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| CEFTRIAXONE SODIUM (2000008050) | JIANGSU SAINTEK COMPANY LIMITED, 5TH FLOOR, 327 WEST TONGFENG ROAD, KUNSHAN, JIANGSU, CN 215300, CHINA IFFECT CHEMPHAR COMPANY LIMITED, 38/F INTERNATIONAL SCIENCE & TECHNOLOGY BUILDING, 3007 SHENNAN ROAD, FUTIAN DISTRICT, SHENZHEN, CN 518033, CHINA XIAMEN FINE CHEMICAL IMPORT & EXPORT COMPANY LIMITED, 1402, 14F FUND BUILDING, 20 SOUTH HUBIN ROAD, XIAMEN, CN-361004, CHINA |
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| ATORVASTATIN (1000008348) | DEPEW FINE CHEMICALS COMPANY LIMITED, 15 F-K, NO 173 YUGU ROAD, HANGZHOU, CN 310007, CHINA IFFECT CHEMPHAR COMPANY LIMITED, 38/F INTERNATIONAL SCIENCE & TECHNOLOGY BUILDING, 3007 SHENNAN ROAD, FUTIAN DISTRICT, SHENZHEN, CN 518033, CHINA HANGZHOU VIWA COMPANY LIMITED, BLOCK D, 17F LANTIAN BUSINESS CENTRE, 18 MOGANSHAN ROAD, HANGZHOU, CN 310005, CHINA |
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| CONJUGATED ESTROGENS (2000012395) | SHANDONG TOPSCIENCE BIO-TECH COMPANY LIMITED, C/O QINGDAO LONGBIDELLY TRADING,, NO. 467 HANGZHOU ROAD, JIAZHOU CITY, QINGDAO, CN-266100, CHINA HANGZHOU LONGSHINE BIO-TECH COMPANY LIMITED, RM13C INTERNATIONAL GARDEN (W), 160 TUANMUSHAN ROAD, HANGZHOU, CN-310007, CHINA HANGZHOU VIWA COMPANY LIMITED, BLOCK D, 17F LANTIAN BUSINESS CENTRE, 18 MOGANSHAN ROAD, HANGZHOU, CN 310005, CHINA |
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| NALBUPHINE HYDROCHLORIDE (2000008240) | RUSAN PHARMA LIMITED, 58-D GOVERNMENT INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W), MUMBAI, IN 400 067, INDIA CLEO SHANGHAI, ROOM 2701, NO. 30 LANE 555, WUYI ROAD, SHANGHAI, CN-200 050, CHINA |
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| MAGNESIUM GLYCEROPHOSPHATE (2000012211) | TRIVENI INTERCHEM PRIVATE LIMITED, 134 PANCHRATNA, CHAR RASTA, G.I.D.C, VAPI, GUJARAT, IN-396195, INDIA INDUSTRIAL TRADING COMPANY, A/304 NEELAM CENTRE, 3RD FLOOR, 249-B HIND CYCLE ROAD, WORLI, MUMBAI, IN-40025, INDIA I B I S CHEMIE PRIVATE LIMITED, 211 DALAMAL CHAMBERS, NEW MARINE LINES, MUMBAI, IN-400 020, INDIA |
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| SCOPOLAMINE HYDROBROMIDE (4000007162) | ALCHEM INTERNATIONAL LIMITED, PLOT NO 25/2, MATHURA ROAD, VILLAGE KALLI, BALLABGARH, FARIDABAD, HARYANA, IN-121004, INDIA TOTEMCHEM COMPANY LIMITED, ROOM 318, NO. 368 HANJIANG AVENUE, XINBEI DISTRICT, CHANGZHOU, JIANGSU, CN 215011, CHINA |
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| PHYTOSTEROLS UNSPECIFIED (1000017784) | ZEON-HEALTH INDUSTRIES, 101 SAI SIDDHI BUILDING, SECTOR 3, NEAR AIROLI BUS DEPOT, AIROLI, NAVI MUMBAI, IN-400708, INDIA HANGZHOU ONICON CHEMICAL COMPANY LIMITED, 303-306 HANGZHOU PHARMACEUTICAL BUILDING, 439 NORTH ZHONGSHAN ROAD, HANGZHOU, ZHEJIANG, CN-310003, CHINA HANGZHOU GREENSKY BIOLOGICAL TECH COMPANY LIMITED, 17TH FLOOR, 2 CHAOWANG ROAD, HANGZHOU, ZHEJIANG, CN-31400, CHINA IKEDA TRADING COMPANY LIMITED, 1-4-5 AZUCHI MACHI, CHUO-KU, OSAKA, JP-541-0052, JAPAN |
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| SILYMARIN (2000013037) | PANJIN TIANYUAN PHARMACEUTICAL COMPANY LIMITED, GAOSHENG TOWN, PANJIN CITY, LIAONING PROVINCE, CN-124123, CHINA SHANXI JIAHE PHYTOCHEM COMPANY LIMITED, ROOM B2705, SEASTAR PLAZA, 37 KEJI ROAD, XI'AN, CN-71005, CHINA HUZHOU NBC BIO & RAW MATERIAL COMPANY LIMITED, 205TH - NO.4299 YINDU ROAD, MINHANG DISTRICT, SHANGHAI, CN-201108, CHINA |
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| HUMAN SERUM ALBUMIN (4000009214) | BIOMEDICAL RESOURCES, 21 NORTH YORK ROAD, PO BOX 490, HATBORO, 19040, UNITED STATES |
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| STRYCHNINE HYDROCHLORIDE (1000006664) | MEHTA PHARMACEUTICALS PRIVATE LIMITED, G.T. ROAD, CHEHARTA, AMRITSAR, PUNJAB, IN-143105, INDIA ALIGNS INTERNATIONAL, 320/322 SARDAR GRIHA BUILDING, 198 LT MARG, CRAWFORD MARKET, MUMBAI, IN-400001, INDIA INDO WORLD TRADING CORPORATION, B-11/6 MOHAN CO-OPERATIVE INDUSTRIAL ESATE, BADARPUR, NEW DELHI, IN-110 044, INDIA |
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| TRANEXAMIC ACID (1000009308) | HUNAN DONGTING PHARMACEUTICAL COMPANY LIMITED, NO.16 DONGYANG ROAD, DESHAN, CHANGDE CITY, HUNAN PROVINCE, CN-415001, CHINA CLEO SHANGHAI, ROOM 2701, NO. 30 LANE 555, WUYI ROAD, SHANGHAI, CN-200 050, CHINA HEFEI TNJ CHEMICAL INDUSTRY COMPANY LIMITED, B911 XINCHENG BUSINESS CENTRE, QIANSHAN ROAD, HEFEI CITY, ANHUI PROVINCE, CN-230022, CHINA |
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| NORETHISTERONE (1000009666) | SHENZHEN BODA BIOPHARM COMPANY LIMITED, ROOM 1605, SICHUAN BUILDING, FUTIAN DISTRICT, HONGLI ROAD, SHENZHEN, CN-518028, CHINA TIANJIN TIANMAO TECHNOLOGY DEVELOPMENT CORPORATION LIMITED, HI-TECH BUILDING A, ROOM 507-511, HUATIAN ROAD, HUAYUAN INDUSTRY PARK, TIANJIN, CN-300384, CHINA XIAMEN SPECIAL ECONOMIC ZONE (SEZ), 12-15/F METAL & MINERALS BUILDING, NO. 226 DONGDU ROAD, XIAMEN, CN-361012, CHINA |
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| MYCOPHENOLATE MOFETIL (2000007706) | ALIGNS INTERNATIONAL, 320/322 SARDAR GRIHA BUILDING, 198 LT MARG, CRAWFORD MARKET, MUMBAI, IN-400001, INDIA HANGZHOU PHARMA & CHEM COMPANY LIMITED, 139 QINGCHUN ROAD, HANGZHOU ZHEJIANG, CN-310003, CHINA HUADONG MEDICINE CO. LIMITED, XIANGFU BRIDGE, NO 866 MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, Data Not Available, CHINA |
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| METHOTREXATE (1000011976) | IFFECT CHEMPHAR COMPANY LIMITED, 38/F INTERNATIONAL SCIENCE & TECHNOLOGY BUILDING, 3007 SHENNAN ROAD, FUTIAN DISTRICT, SHENZHEN, CN 518033, CHINA SHENZHEN BODA BIOPHARM COMPANY LIMITED, ROOM 1605, SICHUAN BUILDING, FUTIAN DISTRICT, HONGLI ROAD, SHENZHEN, CN-518028, CHINA LIANYUNGANG GUI YUAN CHEMPHARM, C24 ORIENTAL GARDEN, XINPU, LIANYUNGANG, JIANGSU, CN-222006, CHINA |
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| PROTAMINE SULPHATE (4000010193) | ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, 5TH FLOOR, IKEDA BUILDING, 1 BANCHI KANDA KITANORIMONO-CHO, CHIYODA-KU, TOKYO, JP-101-0036, JAPAN |
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| WHITE WINE POWDER (2000016906) | SATO FOOD INDUSTRIES, 4-154 HORINOUCHI, KOMAKI CITY, AICHI, JP-485-8523, JAPAN |
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| 5-FLUOROURACIL (3000006377) | SHAANXI MEDICINES & HEALTH PRODUCTS I-E CORPORATION, 37 LIAN HU ROAD, XIAN, CN 710003, CHINA LIANYUNGANG GUI YUAN CHEMPHARM, C24 ORIENTAL GARDEN, XINPU, LIANYUNGANG, JIANGSU, CN-222006, CHINA |
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| COLCHICINE (1000003882) | ALCHEM INTERNATIONAL LIMITED, PLOT NO 25/2, MATHURA ROAD, VILLAGE KALLI, BALLABGARH, FARIDABAD, HARYANA, IN-121004, INDIA INDO WORLD TRADING CORPORATION, B-11/6 MOHAN CO-OPERATIVE INDUSTRIAL ESATE, BADARPUR, NEW DELHI, IN-110 044, INDIA ALIGNS INTERNATIONAL, 320/322 SARDAR GRIHA BUILDING, 198 LT MARG, CRAWFORD MARKET, MUMBAI, IN-400001, INDIA |
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| OXYTOCIN (1000009622) | SANTOW LABORATORY LIMITED, ROOM 1571 MACALLING, NO.1 SHANGDU ROAD, ZHENGZHOU CITY, CN-450047, CHINA |
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| PROSTAGLANDIN E2 (3000010789) | RISING PHARMACEUTICAL INTERNATIONAL COMPANY LIMITED, 217 YAXING, NINGBO ECONOMIC & TECHNICAL DEVELOPMENT AREA, ZHEJIANG, CN-315 803, CHINA CLEO SHANGHAI, ROOM 2701, NO. 30 LANE 555, WUYI ROAD, SHANGHAI, CN-200 050, CHINA SHANGHAI TECHWELL BIOPHARMACEUTICAL COMPANY LIMITED, NO.4258 JINDU ROAD, SHANGHAI, CN-201108, CHINA |
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| PODOPHYLLOTOXIN (1000014185) | LIANYUNGANG GUI YUAN CHEMPHARM, C24 ORIENTAL GARDEN, XINPU, LIANYUNGANG, JIANGSU, CN-222006, CHINA INDO WORLD TRADING CORPORATION, B-11/6 MOHAN CO-OPERATIVE INDUSTRIAL ESATE, BADARPUR, NEW DELHI, IN-110 044, INDIA SHAANXI SCIPHAR BIOTECHNOLOGY COMPANY LIMITED, PO BOX 35, BELL TOWER POST OFFICE, 11 TANGXING ROAD, XI'AN, SHAANXI, CN-710003, CHINA |
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| BUPIVACAINE HYDROCHLORIDE (2000008278) | LIANYUNGANG GUI YUAN CHEMPHARM, C24 ORIENTAL GARDEN, XINPU, LIANYUNGANG, JIANGSU, CN-222006, CHINA JIANGSU SAINTEK COMPANY LIMITED, 5TH FLOOR, 327 WEST TONGFENG ROAD, KUNSHAN, JIANGSU, CN 215300, CHINA MEDIGRAPH PHARMACEUTICALS PRIVATE LIMITED, 301 ERIC HOUSE, 16TH ROAD, CHEMBUR, MUMBAI, IN-400 071, INDIA |
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| RICINUS COMMUNIS (1000004001) | FUQRA ENTERPRISES (PAKISTAN), 148-149 HOTEL METROPOLE, CLUB ROAD, KARACHI, PK-75520, PAKISTAN |
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| CAPSAICIN (1000006807) | ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, 5TH FLOOR, IKEDA BUILDING, 1 BANCHI KANDA KITANORIMONO-CHO, CHIYODA-KU, TOKYO, JP-101-0036, JAPAN SHAANXI MEDICINES & HEALTH PRODUCTS I-E CORPORATION, 37 LIAN HU ROAD, XIAN, CN 710003, CHINA SHAANXI SCIPHAR BIOTECHNOLOGY COMPANY LIMITED, PO BOX 35, BELL TOWER POST OFFICE, 11 TANGXING ROAD, XI'AN, SHAANXI, CN-710003, CHINA |
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| HCG (3000005528) | PARTH OVERSEAS PRIVATE LIMITED, OPP. INDIRA CONTAINER YARD, MULUND-GOREGOAN LINK ROAD, NEAR NAHUR RAILWAY STATION, BHANDUP (W), MUMBAI, IN-400 078, INDIA HANGZHOU LONGSHINE BIO-TECH COMPANY LIMITED, RM13C INTERNATIONAL GARDEN (W), 160 TUANMUSHAN ROAD, HANGZHOU, CN-310007, CHINA SHANDONG TOPSCIENCE BIO-TECH COMPANY LIMITED, C/O QINGDAO LONGBIDELLY TRADING,, NO. 467 HANGZHOU ROAD, JIAZHOU CITY, QINGDAO, CN-266100, CHINA |
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| BUTORPHANOL (1000007548) | COMFORTCOMMS INDUSTRIAL COMPANY LIMITED, 26D DUSHI HUAYUAN, XINZHOU WEST ROAD, FUTIAN, SHENZHEN, GUANGDONG, CN 518104, CHINA |
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| ESTRIOL (3000004591) | IFFECT CHEMPHAR COMPANY LIMITED, 38/F INTERNATIONAL SCIENCE & TECHNOLOGY BUILDING, 3007 SHENNAN ROAD, FUTIAN DISTRICT, SHENZHEN, CN 518033, CHINA HANDE INDUSTRY & TRADE HOLDINGS LIMITED, ROOM 2313-2316, HUANGDU PLAZA, 3008 YITIAN ROAD, SHENZHEN, CN 518048, CHINA HUNAN STERIOD CHEMICALS COMPANY LIMITED, 460 SHAOSHAN ROAD NORTH, CHANGSHA, HUNAN, CN-410 001, CHINA |
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