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)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 10/09/2024 |
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 | |
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | 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 |
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 |
|
| 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 |
|
| 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 |
|
| 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 |
WAVELENGTH ENTERPRISES LIMITED, 29 LEHI STREET, BNEI BRAK, IL-5120050, ISRAEL DR REDDY'S LABORATORIES LIMITED, 8-2-337, ROAD NO. 3, BANJARA HILLS, HYDERABAD, TELANGANA, IN-500034, INDIA |
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| NICOTINE (1000009685) | SIEGFRIED LIMITED, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
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| ACETYLSALICYLIC ACID (3000006351) | NOVACYL (THAILAND) LIMITED, 321 BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKARN, TH-10280, THAILAND |
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| 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 |
|
| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA GRANULES INDIA LIMITED, H.NO.6-5 & 6-11 TEMPLE ROAD, GUMMADIDALA MANDAL, SANGAREDDY DISTRICT, BONTHAPALLY VILLAGE, TELANGANA, IN-502313, INDIA NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA 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 |
|
| CLEMASTINE HYDROGEN FUMARATE (4000007270) | SEKISUI MEDICAL CO. LIMITED - IWATE PLANT, 4-115, MATSUO, HACHIMANTAI, IWATE, JP-028-7305, JAPAN |
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| 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 |
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| 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 |
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| CHLORPHENIRAMINE (1000004563) | KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA CITY, TOYAMA, JP 930-0912, JAPAN |
SPERA NEXUS INC, 8-2, NIHONBASHI HONCHO 4 CHOME, CHUO-KU, YOKYO, JP 103-8403, 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 |
|
| HYDROXYETHYLRUTOSIDE (1000020118) | HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
HALEON CH SARL, ROUTE DE L'ETRAZ, NYON, CH-1260, SWITZERLAND |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | |||
| XYLOMETAZOLINE HYDROCHLORIDE (2000008466) | |||
| TYROTHRICIN (1000009265) | |||
| DIMETINDENE MALEATE (4000007009) | |||
| FLUTICASONE PROPIONATE (2000008220) | |||
| CITRIC ACID ANHYDROUS (3000004479) | |||
| SODIUM CARBONATE ANHYDROUS (3000014431) | |||
| ACETYLSALICYLIC ACID (3000006351) | |||
| BENZONATATE (1000016641) | |||
| CAFFEINE ANHYDROUS (3000005457) | |||
| DICLOFENAC DIETHYLAMINE (2000009017) | |||
| TERBINAFINE HYDROCHLORIDE (2000008315) | |||
| SODIUM BICARBONATE (1000009540) | |||
| IBUPROFEN (1000008918) | |||
| IPRATROPIUM BROMIDE (2000008626) | |||
| CALCIUM CARBONATE (2000008145) | |||
| LEVOFLOXACIN SODIUM (2000020656) | |||
| BUTAMIRATE CITRATE (2000014515) | |||
| PARACETAMOL (1000009609) | |||
| MAGNESIUM SULPHATE (2000012215) | |||
| ESOMEPRAZOLE (1000000848) | |||
| ALUMINIUM HYDROXIDE (1000013126) | |||
| MUPIROCIN (1000000610) | |||
| MAGNESIUM HYDROXIDE (1000000894) | |||
| HYDROXYETHYLRUTOSIDE (1000020118) | |||
| DICLOFENAC SODIUM (2000007774) | |||