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 142 |
| 2. Name or corporate name of registrant | ACCORD-UK LIMITED |
| 3. Permanent or legal address of registrant | ACCORD-UK LIMITED, WHIDDON VALLEY, BARNSTAPLE, EX32 8NS, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ACCORD-UK LIMITED, WHIDDON VALLEY, BARNSTAPLE, EX32 8NS, 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 | 18/10/2024 |
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
ACCORD-UK LIMITED, WHIDDON VALLEY, BARNSTAPLE, EX32 8NS, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| PROPRANOLOL HYDROCHLORIDE (2000007892) | SAI SUPREME CHEMICALS, PLOT NO. F7, SIPCOT INDUSTRIAL COMPLEX, GUMMIDIPOONDI, THIRUVALLUR DISTRICT, TAMIL NADU, IN-601201, INDIA IPCA LABORATORIES LIMITED, P.O. SEJAVTA, RATLAM, MADHYA PRADESH, IN-457001, INDIA |
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| NICOTINAMIDE (2000012339) | LONZA GUANGZHOU NANSHA LIMITED, 68 HUANGGE DADAOBEI, NANSHA DISTRICT, GUANGZHOU, GUANGDONG, CN-511 455, CHINA |
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| TETRACYCLINE HYDROCHLORIDE (2000007377) | NINGXIA QIYUAN PHARMACEUTICAL COMPANY LIMITED, NO 1 QIYUAN STEET, WANGYUAN INDUSTRIAL AREA, YINCHUAN, NINGXIA, CN-750101, CHINA |
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| METHYLDOPA (1000000089) | ZHEJIANG WILD WIND PHARMACEUTICAL CO. LT, BEIJIANG INDUSTRIAL ZONE, GESHAN TOWN, DONGYANG, ZHEJIANG, CN-322105, CHINA |
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| DIGOXIN (1000003095) | DECCAN NUTRACEUTICALS PVT LIMITED (PART OF ALKALOIDS CORPORATION), GAT NO. 1065, GOLEGAON ROAD, OFF ALANDI MARKAL ROAD, VILLAGE MARKAL, TALUKA KHED, PUNE, MAHARASHTRA, IN 412105, INDIA |
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| FOLIC ACID (1000001996) | HEBEI JIHENG (GROUP) PHARMACEUTICAL, NO.1 WEIWU STREET, HENGSHUI INDUSTRIAL PARK, HENGSHUI CITY, HEBEI PROVINCE, CN-053 000, CHINA SRI KRISHNA PHARMACEUTICALS LIMITED, UNIT III, SURVEY NO 57, GOLKONDA KALAN, RAIKUNTA VILLAGE, SHAMSHABAD MANDAL, TELANGANA, IN-501218, INDIA |
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| GLICLAZIDE (1000001769) | ZHEJIANG JIUZHOU PHARMACEUTICAL, 99 WAISHA ROAD, JIAOJIANG, TAIZHOU CITY, ZHEJIANG, CN-318 000, CHINA |
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| PREDNISOLONE (1000009794) | HENAN LIHUA PHARMACEUTICAL CO LIMITED, MIDDLE OF HUANGHE STREET, ANYANG HI-TECH INDUSTRY DEVELOPMENT ZONE, ANYANG, HENAN, CN-455000, CHINA SHANDONG XINHUA PHARMACEUTICAL CO., LIMITED., HUTIAN CHEMICAL INDUSTRIAL ZONE, ZIBO, SHANDONG PROVINCE, CN-255086, CHINA TIANJIN TIANYAO PHARMACEUTICALS CO. LIMITED, 19 XINYE 9TH STREET, WEST AREA OF TEDA, TIANJIN, CN-300 462, CHINA |
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| PIROXICAM (1000009856) | ARCH PHARMALABS LIMITED, C-21/22 AND F-40, MIDC, PHASE II, MANDAPA ROAD, SAGAON, THANE, MAHAHRASHTRA, IN-421204, INDIA |
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| PARACETAMOL COMPAP PVP3 (2000017331) | SPECGX LLC - GREENVILLE, 100 LOUIS LATZER DRIVE, GREENVILLE, 62246, UNITED STATES |
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| SULPHAMETHOXAZOLE (1000009392) | VIRCHOW LABORATORIES LIMITED, PLOT NO 4 TO 10 S.V.COOPERATIVE INDUSTRIAL ESTATE, I.D.A. JEEDIMETLA, HYDERABAD, IN 500055, INDIA |
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| FUROSEMIDE (3000005943) | IPCA LABORATORIES LIMITED, P.O. SEJAVATA, RATLAM, MADHYA PRADESH, IN-457002, INDIA |
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| SPIRONOLACTONE MICRONISED (2000018722) | TIANJIN JINJIN PHARMACEUTICAL CO. LIMITED, 8 JINGFU ROAD, ZHANGJIAWO TOWN INDUSTRIAL ZONE, XIQING DISTRICT ECONOMIC AND DEVELOPMENT AREA, ZHANGJIAWO, TIANJIN, CN-300380, CHINA |
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| DOXYCYCLINE HYCLATE (4000006937) | YANGZHOU LIBERTY PHARMACEUTICAL COMPANY LIMITED, 22 YANGLI ROAD, HANJIANG INDUSTRIAL PARK, YANGZHOU, JIANGSU PROVINCE, CN-225 127, CHINA |
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| FENOFIBRATE (1000002301) | WAVELENGTH ENTERPRISES LIMITED, NEOT HOVAV ECO INDUSTRIAL PARK, P.O.BOX 3593, BEER SHEVA, IL-8413502, ISRAEL VANAMALI ORGANICS PRIVATE LIMITED, PLOT NO. 24A AND 24B, TSIIC, SURVEY NO.480, IDA MANKHAL, MAHESWARAM MANDAL, RANGAREDDY DISTRICT, TELANGANA, IN- 501 359, INDIA |
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| HYDRALAZINE HYDROCHLORIDE (2000007339) | HETERO LABS LIMITED, UNIT I, SURVEY NO.10, I.D.A., GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502 319, INDIA |
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| DAPSONE (1000003787) | ATUL LIMITED, NORTH SITE, PO ATUL, VALSAD, GUJARAT, IN-396020, INDIA |
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| FLECAINIDE ACETATE (2000007515) | MAPRIMED ARGENTINA, CORONEL PRUDENCIO MURGUIONDO 2011, BUENOS AIRES, AR-1440, ARGENTINA |
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| BUPRENORPHINE HYDROCHLORIDE (2000008277) | SPECGX LLC ST LOUIS, 3600 NORTH SECOND STREET, ST LOUIS, 63147, UNITED STATES SIEGFRIED AG, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, 4800, SWITZERLAND SIEGFRIED (USA) INCORPORATED, 33 INDUSTRIAL PARK ROAD, PENNSVILLE, 08070, UNITED STATES |
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| THIAMINE HYDROCHLORIDE (4000010937) | JIANGXI TIANXIN PHARMACEUTICAL, LE'ANJIANG INDUSTRIAL ZONE, LEPING, ZIANGXI, CN-333300, CHINA |
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| NAPROXEN (1000009701) | DIVIS LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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| PHENOBARBITAL (1000014071) | HARMAN FINOCHEM LIMITED, PLOT NO. A-100, A-100-1, A-100-2, D-1, MIDC INDUSTRIAL AREA, SHENDRA, AURANGABAD, MAHARASHTRA, IN-431007, INDIA |
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| CLOPIDOGREL BESILATE (2000013668) | ZYDUS LIFESCIENCES LIMITED, PLOT NO. 26 TO 29 AND 31, DABHASA UMARAYA ROAD, VADODARA DISTRICT, DABHASA VILLAGE, GUJARAT, IN-391440, INDIA |
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| HYDROCORTISONE MICRONISED (3000010308) | PHARMACIA & UPJOHN COMPANY, 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
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| PROGESTERONE (1000009777) | ZHEJIANG SHENZHOU PHARMACEUTICAL NO.9, NO. 9 HONGYUN ROAD, XIANDAI INDUSTRIAL ZONE, TAIZHOU, XIANJU, ZHEJIANG PROVINCE, CN-317300, CHINA PHARMACIA & UPJOHN COMPANY, 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES |
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| GABAPENTIN (1000007380) | HIKAL LIMITED, 72 & 82/A, KIADB INDUSTRIAL AREA, JIGANI, ANEKAL TALUK, BANGALORE, KARNATAKA, IN-560105, INDIA |
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| BENDROFLUMETHIAZIDE (3000006463) | UNICHEM LABORATORIES LIMITED, PLOT NO 99, MIDC AREA, VILLAGE DHATAV-ROHA, RAIGAD, MAHARASHTRA, IN-402 116, INDIA IPCA LABORATORIES LIMITED, P.O. SEJAVTA, RATLAM, MADHYA PRADESH, IN-457002, INDIA |
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| TRAMADOL HYDROCHLORIDE (2000008034) | M/S VIRUPAKSHA ORGANICS LIMITED, SURVEY NO 10, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL, MEDAK DISTRICT, TELANGANA, IN-502 319, INDIA EMNAR PHARMA PRIVATE LIMITED, PLOT NO. 15, JAWAHARLAL NEHRU PHARMA CITY, PARAWADA MANDA, VISAKAPATNAM DISTRICT, TADI VILLAGE, ANDHRA PRADESH, IN-531 019, INDIA |
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| LISINOPRIL DIHYDRATE (2000008500) | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LIMITED, CHUANNAN NO 1 BRANCH FACTORY, COASTAL INDUSTRIAL ZONE, DUQIAO, LINHAI, ZHEJIANG PROVINCE, CN-317016, CHINA |
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| AMITRIPTYLINE HYDROCHLORIDE (2000008522) | R L FINE CHEM (KIADB), PLOT NO IP-27-29, KIADB INDUSTRIAL AREA, 1ST PHASE, KUDUMALAKUNTE VILLAGE, GAURIBIDANUR TALUK, CHIKKABALLAPUR DISTRICT, KARNATAKA, IN-561208, INDIA |
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| DIPYRIDAMOLE (1000002962) | MYLAN LABORATORIES LIMITED, UNIT 9, PLOT NO. 5, ROAD NO 12, JAWAHARLAL NEHRU PHARMA CITY, TADI VILLAGE, PARAWADA MANDAL, ANAKAPALLI DISTRICT, VISAKHAPATNAM, ANDHRA PRADESH, IN-531019, INDIA |
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| AZITHROMYCIN DIHYDRATE (2000007794) | ZHJIEANG GUOBANG PHARMACEUTICAL CO. LIMITED, NO. 6 WEIWU ROAD, HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANGYU, ZHEJIANG, CN-312 369, CHINA |
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| NALOXONE HYDROCHLORIDE MICRONISED (4000016916) | VERANOVA L.P., 2003 NOLTE DRIVE, WEST DEPTFORD, 08066, UNITED STATES |
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| MIRTAZAPINE (1000003365) | ZHEJIANG LIAOYUAN PHARMACEUTICAL LIMITED, ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RAW MATERIAL, BASE LINHAI ZONE, DUQIAO TOWN, LINHAI CITY, ZHEJIANG PROVINCE, CN-317 016, CHINA NEULAND LABORATORIES LIMITED, UNIT 1, BONTHAPALLI VILLAGE, VEERABHADRASWAMY TEMPLE ROAD, JINNARAM MANDAL, MEDAK DISTRICT, TELANGANA, IN-502 313, INDIA |
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| ATORVASTATIN CALCIUM TRIHYDRATE (2000005733) | CENTRIENT PHARMACEUTICALS, BHAI MOHAN SINGH NAGAR, TOANSA, NAWANSHAHR, PUNJAB, IN-144 533, INDIA |
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| FLUOXETINE HYDROCHLORIDE (2000008390) | CADILA PHARMACEUTICALS LIMITED, PLOT NO. 294, GIDC INDUSTRIAL ESTATE, BHARUCH DISTRICT, ANKLESHWAR, GUJARAT, IN-393002, INDIA |
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| CALCIUM GLUCONATE (2000011072) | ZHEJIANG RUIBANG LABORATORIES, NO 578 BINHAI TEN ROAD, ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, WENZHOU, ZHEJIANG PROVINCE, CN-325025, CHINA |
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| SALBUTAMOL SULPHATE (2000007742) | NEULAND LABORATORIES LIMITED, UNIT 1, SURVEY NO. 347, 473, 474, 490/2, VEERABHADRASWAMY TEMPLE ROAD, BONTHAPALLI VILLAGE, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502313, INDIA |
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| TRIMETHOPRIM (1000009283) | SHOUGUANG FUKANG PHARMACEUTICAL COMPANY LIMITED, NORTH-EAST OF DONGWAIHUAN ROAD, DONGCHENG INDUSTRIAL AREA, SHOUGUANG, SHANDONG PROVINCE, CN-262700, CHINA |
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| ACICLOVIR (3000006349) | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO. LIMITED, TONGYUANXI, DAZHAN, XIANJU, ZHEJIANG PROVINCE, CN-317 321, CHINA |
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| PARACETAMOL (1000009609) | SPECGX LLC, RALEIGH PHARMACEUTICAL PLANT, 8801 CAPITAL BOULEVARD, RALEIGH, 27616-3116, UNITED STATES SHENZHOU JIHENG PHARMACEUTICAL CO., LIMITED., WEST OF GUOXIN ROAD, XIJINGMING VILLAGE, DONG'ANZHUANG TOWNSHIP, SHENZHOU COUNTY, HENGSHUI CITY, HEBEI PROVINCE, CN-053 800, CHINA HEBEI JIHENG (GROUP) PHARMACEUTICAL, NO.1 WEIWU STREET, HENGSHUI INDUSTRIAL PARK, HENGSHUI CITY, HEBEI PROVINCE, CN-053 000, CHINA |
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| IMIPRAMINE HYDROCHLORIDE (2000007321) | TEVA API INDIA PRIVATE LIMITED, PLOT NOS Q1 TO Q4, INDUSTRIAL AREA, GHIRONGI, MALANPUR, BHIND, MADHYA PRADESH, IN-477 117, INDIA |
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