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 41517 |
| 2. Name or corporate name of registrant | HALEON UK TRADING SERVICES LIMITED |
| 3. Permanent or legal address of registrant | HALEON UK TRADING SERVICES LIMITED, BUILDING 5, FIRST FLOOR, THE HEIGHTS, BROOKLANDS, WEYBRIDGE, KT13 0NY, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
HALEON UK TRADING SERVICES LIMITED, BUILDING 5, FIRST FLOOR, THE HEIGHTS, BROOKLANDS, WEYBRIDGE, KT13 0NY, 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 | 02/06/2023 |
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
HALEON UK TRADING SERVICES LIMITED, BUILDING 5, FIRST FLOOR, THE HEIGHTS, BROOKLANDS, WEYBRIDGE, KT13 0NY, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| ACETYLSALICYLIC ACID (3000006351) | NOVACYL (THAILAND) LIMITED, 321 BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKARN, TH-10280, THAILAND |
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| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA MALLADI DRUGS AND PHARMACEUTICALS LIMITED, UNIT 3 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET DISTRICT, RANIPET, TAMIL NADU, IN-632403, INDIA |
DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA MALLADI DRUGS AND PHARMACEUTICALS LIMITED, UNIT 3 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET DISTRICT, RANIPET, TAMIL NADU, IN-632403, INDIA |
|
| PHENIRAMINE MALEATE (2000008073) | SUPRIYA LIFESCIENCE LIMITED, A-5/2 LOTE PARSHURAM INDUSTRIAL AREA, MIDC, TALUKA KHED, RATNAGIRI, MAHARASHTRA, IN-415 722, INDIA |
SUPRIYA LIFESCIENCE LTD, UDYOG BHAVAN, SONAWALA ROAD, GOREGAON EAST, MUMBAI, MAHARASHTRA, IN-400063, INDIA |
|
| CHLORPHENIRAMINE (1000004563) | KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA CITY, TOYAMA, JP 930-0912, JAPAN |
IWAKI & CO., LIMITED, 8-2, NIHONBASHI HONCHO 4 CHOME, CHUO-KU, YOKYO, JP 103-8403, JAPAN |
|
| CODEINE PHOSPHATE HEMIHYDRATE (4000006570) | SUN PHARMACEUTICAL INDUSTRIES (AUSTRALIA) PTY LIMITED, PRINCES HIGHWAY, PORT FAIRY, AU-VIC 3284, AUSTRALIA |
SUN PHARMACEUTICAL INDUSTRIES (AUSTRALIA) PTY LIMITED, PRINCES HIGHWAY, PORT FAIRY, AU-VIC 3284, AUSTRALIA |
|
| CAFFEINE ANHYDROUS (3000005457) | SHANDONG XINHUA PHARMACEUTICAL CO. LIMITED, EAST CHEMICAL ZONE OF ZIBO HIGH & NEW TECHNOLOGY DEVELOPMENT ZONE, ZHANGDIAN DISTRICT, ZIBO, SHANDONG, CN-255 075, CHINA |
SHANDONG XINHUA PHARMACEUTICAL CO LIMITED, MODERN PHARMACEUTICAL INTERNATIONAL COOPERATION CENTER, NO.1 LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, CN-255086, CHINA |
|
| NICOTINE (1000009685) | SIEGFRIED LIMITED, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
SIEGFRIED LIMITED, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
|
| HYDROXYETHYLRUTOSIDE (1000020118) | GSK CONSUMER HEALTHCARE S.A., ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
GSK CONSUMER HEALTHCARE S.A., ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
|
| CLEMASTINE HYDROGEN FUMARATE (4000007270) | SEKISUI MEDICAL CO. LIMITED - IWATE PLANT, 4-115, MATSUO, HACHIMANTAI, IWATE, JP-028-7305, JAPAN |
SEKISUI MEDICAL CO. LIMITED - IWATE PLANT, 4-115, MATSUO, HACHIMANTAI, IWATE, JP-028-7305, JAPAN |
|
| PARACETAMOL (1000009609) | GRANULES INDIA LIMITED, H.NO.6-5 & 6-11 TEMPLE ROAD, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, BONTHAPALLY VILLAGE, TELANGANA, IN-502 313, INDIA ANQIU LU'AN PHAMACEUTICAL CO. LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA |
FARMSON PHARMACEUTICAL PHARMACEUTICAL GUJARAT PVT LIMITED, 28-35 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA, GUJARAT, IN-391 340, INDIA NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA GRANULES INDIA LIMITED, SECOND FLOOR, THIRD BLOCK, MY HOME HUB, MADHAPUR, HYDERABAD, TELANGANA, IN 500081, INDIA ANQIU LU'AN PHAMACEUTICAL CO. LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA |
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| CETIRIZINE DIHYDROCHLORIDE (4000006373) | WAVELENGTH ENTERPRISES LIMITED, NEOT-HOVAV ECO-INDUSTRIAL PARK, BEER SHEVA, IL-8413502, ISRAEL |
WAVELENGTH ENTERPRISES LIMITED, 29 LEHI STREET, BNEI BRAK, IL-5120050, ISRAEL |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CITRIC ACID ANHYDROUS (3000004479) | |||
| BENZONATATE (1000016641) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| SODIUM CARBONATE ANHYDROUS (3000014431) | |||
| CAFFEINE ANHYDROUS (3000005457) | |||
| IBUPROFEN (1000008918) | |||
| TYROTHRICIN (1000009265) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| HYDROXYETHYLRUTOSIDE (1000020118) | |||
| BUTAMIRATE CITRATE (2000014515) | |||
| DIMETINDENE MALEATE (4000007009) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| MAGNESIUM HYDROXIDE (1000000894) | |||
| ESOMEPRAZOLE (1000000848) | |||
| PARACETAMOL (1000009609) | |||
| ALUMINIUM HYDROXIDE (1000013126) | |||
| MAGNESIUM SULPHATE (2000012215) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| SODIUM BICARBONATE (1000009540) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| LEVOFLOXACIN SODIUM (2000020656) | |||
| MUPIROCIN (1000000610) | |||