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 63 |
| 2. Name or corporate name of registrant | RECKITT BENCKISER HEALTHCARE (UK) LIMITED |
| 3. Permanent or legal address of registrant | RECKITT BENCKISER HEALTHCARE (UK) LIMITED, DANSOM LANE, HULL, HU8 7DS, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
RECKITT BENCKISER HEALTHCARE (UK) LIMITED, DANSOM LANE, HULL, HU8 7DS, 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 | 31/03/2025 |
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 (UK) LIMITED, DANSOM LANE, HULL, HU8 7DS, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| MEBEVERINE HYDROCHLORIDE (2000008414) | RA CHEM (FDF DIVISION) PLOT NO. A-19/C, A23A, A23B, PLOT NO. A-19/C, A-23A & A-23B, ROAD NO. 18, I.D.A, ROAD NO. 18, IDA, NACHARAM, MEDCHAL-MALKAJGIRI DISTRICT, TELANGANA, IN-500076, INDIA RA CHEMICALS AND INTERMEDIATES PRIVATE LIMITED, R.S. 50/1, MUKTESWARAPURAM VILLAGE, KRISHNA DISTRICT, JAGGAIAHPETA, ANDHRA PRADESH, IN-521 175, INDIA |
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| SODIUM BICARBONATE (1000009540) | SUDEEP PHARMA PRIVATE LIMITED, PLOT NO. 129/1/A & 129/12, 13, 14, 15 GIDC ESTATE, NANDESARI, VADODARA, GUJARAT, IN-391340, INDIA |
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| ISPAGHULA HUSK (4000010150) | JYOTINDRA INTERNATIONAL, 4.0 KM PALANPUR-AHMEDABAD HIGHWAY, PALANPUR, GUJARAT, IN-385 001, INDIA KAMAL & SONS, KAMAL ESTATE, STATE HIGHWAY, SUJANPUR CROSSING, SIDHPUR, GUJARAT STATE, IN-384 151, INDIA SATNAM PSYLLIUM INDUSTRIES, STATE HIGHWAY AT & PO, BRAHMANVANDA, TALUK UNJHA, DISTRICT MEHSANA, GUJARAT, IN 384215, INDIA |
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| ACETYLSALICYLIC ACID (3000006351) | THE ANDHRA SUGARS LIMITED, VENKATARAYAPURAM, TANUKU, ANDHRA PRADESH, IN-534215, INDIA |
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| DEXTROMETHORPHAN HYDROBROMIDE (2000007835) | MALLADI DRUGS & PHARMACEUTICALS LIMITED, PLOT NOS. 49, 50, 55, 56, IDA, GAJULAMANDYAM, ATTUR (P.O.), RENIGUNTA, ANDHRA PRADESH, IN-517 520, INDIA DIVI'S LABORATORIES LIMITED, UNIT 1, LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, TELANGANA, IN-508252, INDIA |
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| PARACETAMOL (1000009609) | ANQIU LU'AN PHARMACEUTICAL COMPANY LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 199, CHINA FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED, PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
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| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | MALLADI DRUGS & PHARMACEUTICALS LIMITED, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
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| TRIPROLIDINE HYDROCHLORIDE (2000008490) | HIKAL LIMITED, 28/A, K.I.A.D.B. INDUSTRIAL AREA, JIGANI, ANEKAL TALUK, BANGALORE, KARNATAKA, IN 560105, INDIA MALLADI, UNIT 3, 7B AND 7C, SIPCOT INDUSTRIAL COMPLEX, RANIPET, RANIPET, TAMIL NADU, IN-632403, INDIA |
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| DIPHENHYDRAMINE (1000002995) | WANBURY LIMITED, K. ILLINDALAPARRU, IRAGAVARAM MANDAL, WEST GODAVARI DISTRICT, TANUKU, ANDHRA PRADESH, IN-534 217, INDIA |
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| GLYCINE (1000012477) | EVONIK, 10 WENJIANG ROAD, WUMING DISTRICT, NANNING, GUANGXI, CN-530100, CHINA |
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| ASCORBIC ACID (1000009903) | CSPC WEISHENG PHARMACEUTICAL (SHIJIAZHUANG) COMPANY LIMITED, NO. 898 ZHONGSHANG EAST ROAD, HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE, SHIJAZHUANG, HEBEI, CN-050 035, CHINA |
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| CALCIUM CARBONATE (2000008145) | SUDEEP PHARMA PRIVATE LIMITED, PLOT NO. 129/1/A & 129/12, 13, 14, 15 GIDC ESTATE, NANDESARI, VADODARA, GUJARAT, IN-391340, 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 SOLARA ACTIVE PHARMA SCIENCES LIMITED, RS NO. 33 & 34, MATHUR ROAD, PERIYAKALAPET, PUDUCHERRY, IN 605014, INDIA |
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| GUAIFENESIN (3000005625) | SYNTHOKEM LABS PRIVATE LIMITED, UNIT-II, PLOT NO 222-224 & 235-237, PHASE-II, IDA, PATANCHERU MANDAL, SANGAREDDY DISTRICT, PASHAMYLARAM, TELANGANA, IN-502 319, INDIA |
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