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, WEYBRIDGE, SURREY, 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 | 12/06/2024 |
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
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 | |
| 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 |
|
| ACETYLSALICYLIC ACID (3000006351) | NOVACYL (THAILAND) LIMITED, 321 BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKARN, TH-10280, THAILAND |
||
| HYDROXYETHYLRUTOSIDE (1000020118) | HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
|
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | SIEGFRIED EVIONNAZ SA, ROUTE DU SIMPLON 1,36, EVIONNAZ, CH-1902, SWITZERLAND |
HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
|
| NICOTINE (1000009685) | SIEGFRIED LIMITED, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
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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, RANIPET, TAMIL NADU, IN-632403, INDIA |
MALLADI DRUGS AND PHARMACEUTICALS LIMITED, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA DIVIS LABORATORIES LIMITED, UNIT 2, CHIPPADA VILLAGE, ANNAVARAM POST, BHEEMUNIPATNAM MANDAL, VISAKHAPATNAM, ANDHRA PRADESH, IN-531 162, INDIA |
|
| CHLORPHENIRAMINE (1000004563) | KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA CITY, TOYAMA, JP 930-0912, JAPAN |
IWAKI SEIYAKU CO LIMITED, 8-2, NIHONBASHI HONCHO, 4-CHOME, CHUO-KU, TOKYO, JP 103-8403, JAPAN |
|
| SENNA GLYCOSIDES (2000021026) | ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, KAMINO PLANT (PRODUCTION), 8 FURUKAWA-CHO KAMINO, HIDA, GIGU PREFECTURE, JP-509-4263, JAPAN |
ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, 10-50 FURUKAWACHO MUKAIMACHI NICHOME, HIDA, GIFU, JP-509 4241, JAPAN |
|
| CETIRIZINE DIHYDROCHLORIDE (4000006373) | DR REDDY'S LABORATORIES LIMITED, CHEMICAL TECHNICAL OPERATIONS UNIT-1, PLOT NOS 137, 138, 145 AND 146, SRI VENKATESWARA CO-OPERATIVE INDUSTRIAL ESTATE, BOLLARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN-502 325, INDIA WAVELENGTH ENTERPRISES LIMITED, NEOT-HOVAV ECO-INDUSTRIAL PARK, BEER SHEVA, IL-8413502, ISRAEL |
DR REDDY'S LABORATORIES LIMITED, 8-2-337, ROAD NO. 3, BANJARA HILLS, HYDERABAD, TELANGANA, IN-500034, INDIA WAVELENGTH ENTERPRISES LIMITED, 29 LEHI STREET, BNEI BRAK, IL-5120050, ISRAEL |
|
| 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 |
|
| DIMETINDENE MALEATE (4000007009) | HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
HALEON CH SARL, 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 |
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| 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 |
|
| PARACETAMOL (1000009609) | NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA GRANULES INDIA LIMITED, H.NO.6-5 & 6-11 TEMPLE ROAD, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, BONTHAPALLY VILLAGE, TELANGANA, IN-502313, INDIA FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA ANQIU LU'AN PHAMACEUTICAL CO. LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA |
GRANULES INDIA LIMITED, SECOND FLOOR, THIRD BLOCK, MY HOME HUB, MADHAPUR, HYDERABAD, TELANGANA, IN-500081, INDIA FARMSON PHARMACEUTICAL PHARMACEUTICAL GUJARAT PVT LIMITED, PLOT NO. 28-35 G.I.D.C. INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA ANQIU LU'AN PHAMACEUTICAL CO. LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| CALCIUM CARBONATE (2000008145) | |||
| MAGNESIUM HYDROXIDE (1000000894) | |||
| DICLOFENAC SODIUM (2000007774) | |||
| SODIUM BICARBONATE (1000009540) | |||
| ACETYLSALICYLIC ACID (3000006351) | |||
| IBUPROFEN (1000008918) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| BENZONATATE (1000016641) | |||
| HYDROXYETHYLRUTOSIDE (1000020118) | |||
| CITRIC ACID ANHYDROUS (3000004479) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| IPRATROPIUM BROMIDE (2000008626) | |||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| SODIUM CARBONATE ANHYDROUS (3000014431) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| MAGNESIUM SULPHATE (2000012215) | |||
| BUTAMIRATE CITRATE (2000014515) | |||
| CAFFEINE ANHYDROUS (3000005457) | |||
| DIMETINDENE MALEATE (4000007009) | |||
| MUPIROCIN (1000000610) | |||
| ALUMINIUM HYDROXIDE (1000013126) | |||
| LEVOFLOXACIN SODIUM (2000020656) | |||
| TYROTHRICIN (1000009265) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| ESOMEPRAZOLE (1000000848) | |||
| PARACETAMOL (1000009609) | |||