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 12862 |
| 2. Name or corporate name of registrant | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED |
| 3. Permanent or legal address of registrant | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, D95 BUILDING, THANE ROAD, NOTTINGHAM, NG90 2DB, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, 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
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DB, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| HAMAMELIS WATER (2000007408) | AMERICAN DISTILLING AND MANUFACTURING GROUP, 31 EAST HIGH STREET, EAST HAMPTON, 06424, UNITED STATES |
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| PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829) | EMBIO LIMITED, PLOT NO E21-22, MIDC INDUSTRIAL ESTATE, RAIGAD DISTRICT, MAHAD, MAHARASHTRA, IN-402309, INDIA MALLADI, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
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| MENTHOL (1000001243) | ANHUI FENGLE PERFUME CO LIMITED, 1 TIANHU ROAD, HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE, HEFEI, ANHUI, CN-230088, CHINA |
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| FLURBIPROFEN (1000002036) | SUN PHARMACEUTICAL INDUSTRIES LIMITED., A7/A8 MIDC INDUSTRIAL AREA, AHMEDNAGAR, MAHARASHTRA, IN-414111, INDIA HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED., PLOT NO. 174, PROGRESSIVE INDUSTRIAL SOCIETY, I.D.A. BOLLARAM, BOLLARAM VILLAGE, JINNARAM MANDAL, SANGAREDDY DISTRICT, TELANGANA, IN 502325, INDIA |
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| BENZOCAINE (1000009160) | CHANGZHOU SUNLIGHT, 216 YUNNAN WEST ROAD, BENNIU TOWN, XINBEI DISTRICT, CHANGZHOU CITY, JIANGSU PROVINCE, CN 213134, CHINA |
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| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | MALLADI, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
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| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | CU CHEMIE UETIKON GMBH, RAIFFEISENSTRASSE 4, LAHR, D-77933, GERMANY BIOXERA, PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, INDIA |
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| IBUPROFEN (1000008918) | IOL CHEMICALS AND PHARMACEUTICALS LIMITED, MANSA ROAD (TRIDENT COMPLEX), DISTRICT BARNALA, FATEHGARH CHANNA VILLAGE, PUNJAB, IN-148101, INDIA BASF CORPORATION, HIGHWAY 77 SOUTH, BISHOP, 78343, UNITED STATES SOLARA ACTIVE PHARMA SCIENCES, RS NO. 33 & 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA |
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| AMYLMETACRESOL (1000000573) | BIOXERA, PLOT NO. N-57, M.I.D.C., ADDITIONAL AMBERNATH, AMBERNATH (EAST), THANE DISTRICT, MUMBAI, MAHARASHTRA, IN 421501, INDIA |
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| IBUPROFEN SODIUM (2000011939) | IOL CHEMICALS AND PHARMACEUTICALS LIMITED, MANSA ROAD (TRIDENT COMPLEX), DISTRICT BARNALA, FATEHGARH CHANNA VILLAGE, PUNJAB, IN-148101, INDIA SOLARA ACTIVE PHARMA SCIENCES, RS NO. 33 & 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA BASF, HIGHWAY 77 SOUTH, BISHOP, 78343, UNITED STATES SOLARA ACTIVE PHARMA SCIENCES, A1/B SIPCOT INDUSTRIAL COMPLEX, KUDIKADU, CUDDALORE, TAMIL NADU, IN-607005, INDIA |
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| PARACETAMOL (1000009609) | SPECGX LLC, RALEIGH PHARMACEUTICAL PLANT, 8801 CAPITAL BOULEVARD, RALEIGH, 27616-3116, UNITED STATES SPECGX LLC, 100 LOUIS LATZER DRIVE, GREENVILLE, 62246, UNITED STATES ANQUI LU'AN PHARMACEUTICAL CO LIMITED, XIAO HE YA, NORTH PART OF THE ANQIU CITY, ANQIU, SHANDONG PROVINCE, CN-262100, CHINA |
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| CALCIUM CARBONATE D/C (4000003925) | SUDEEP PHARMA, 129/1/A, G.I.D.C. ESTATE, NANDESARI, VADODARA, GUJARAT, IN 391340, INDIA |
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| CETYLPYRIDINIUM (1000006275) | VERTELLUS HEALTH AND SPECIALITY PRODUCTS LLC, 215 NORTH CENTENNIAL STREET, ZEELAND, 49464-1309, UNITED STATES |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| 2,4-DICHLOROBENZYL ALCOHOL (3000009479) | |||
| IBUPROFEN (1000008918) | |||