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 49402 |
| 2. Name or corporate name of registrant | AZELIS UK LIMITED |
| 3. Permanent or legal address of registrant | AZELIS UK LIMITED, AXIS HOUSE, TUDOR ROAD, MANOR PARK, RUNCORN, WA7 1BD, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
AZELIS UK LIMITED, FOXHOLES BUSINESS PARK, JOHN TATE ROAD, HERTFORD, SG13 7YH, 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 | 25/04/2025 |
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
AZELIS UK LIMITED, FOXHOLES BUSINESS PARK, JOHN TATE ROAD, HERTFORD, SG13 7YH, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| PHENYLBUTAZONE (1000009893) | NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 43 YAOGANG ROAD, NANTONG, JIANGSU PROVINCE, CN-226 006, CHINA |
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| MAGNESIUM HYDROXIDE (1000000894) | SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES |
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| PHENOBARBITONE (3000014222) | NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 9 XINGTAI ROAD, ZONE GANGZHA, ECONOMIC DEVELOPMENT, NANTONG, JIANGSU, CN-226005, CHINA |
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| CLOPIDOGREL BESILATE (2000013668) | CADILA HEALTHCARE LIMITED, ZYDUS TOWER, 5TH FLOOR-SATELLITE CROSS ROADS, SARKHEJ ROAD, GANDHINAGAR, GUJARAT, IN-380015, INDIA |
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| GRANISETRON (1000009464) | CIPLA LIMITED, MANUFACTURING & RESEARCH DIVISION, OLD MADRAS ROAD, VIRGONAGAR DISTRICT, BANGALORE, KARNATAKA, IN-560 049, INDIA |
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| NOSCAPINE (1000009663) | ALKALOIDS CORPORATION, 8 BENTINCK STREET, KOLKATA, IN-700 001, INDIA |
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| MOMETASONE FUROATE (2000008125) | AURISCO PHARMACEUTICAL LIMITED, ROOM 1709-1710 HITECH PLAZA, NO 488 S WU NING ROAD, SHANGHAI, CN-200 042, CHINA |
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| ALUMINIUM HYDROXIDE (1000013126) | SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES |
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| LISINOPRIL DIHYDRATE (2000008500) | ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
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| PERINDOPRIL ERBUMINE (2000008381) | GLENMARK, PLOT NO. 3109- C, GIDC INDUSTRIAL ESTATE, ANKLESHWAR, DIST. BHARUCH, GUJARAT STATE, IN-393 002, INDIA |
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| PHENYLEPHRINE HYDROCHLORIDE (2000008067) | DIVI'S LABORATORIES LIMITED, DIVI TOWERS 7-1-77/E/1/303 DHARAM KARAN ROAD, AMEERPET, HYDERABAD, TELANGANA, IN-500 016, INDIA |
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| PHENOBARBITAL (1000014071) | NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 9 XINGTAI ROAD, ZONE GANGZHA, ECONOMIC DEVELOPMENT, NANTONG, JIANGSU, CN-226005, CHINA |
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| PARACETAMOL (1000009609) | ANQIU LU'AN PHARMACEUTICAL COMPANY LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 199, CHINA NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA |
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| ENALAPRIL MALEATE (2000007672) | ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
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| PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829) | EMBIO LIMITED, 501 SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI, IN-400 076, INDIA |
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| INDAPAMIDE (1000008739) | SUZHOU LIXIN PHARMACEUTICAL CO., LIMITED., 21 TANGXI ROAD, SUZHOU NEW DISTRICT, SUZHOU, CN-215151, CHINA |
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| CAPTOPRIL (1000006787) | ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA |
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| BENZYL NICOTINATE (1000009481) | HERBERT BROWN PHARMACEUTICAL AND RESEARCH LABORATORIES, W-256-A, MIDC PHASE II, SHIVAJI UDYOG NAGAR, DOMBIVLI, THANE, IN-421203, INDIA |
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| MAGALDRATE (1000001270) | SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES |
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| EPHEDRINE HYDROCHLORIDE (2000007671) | EMBIO LIMITED, 501 SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI, IN-400 076, INDIA |
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| IBUPROFEN (1000008918) | SI GROUP, 725 CANNON BRIDGE ROAD, ORANGEBURG, 29115, UNITED STATES |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| DIMETHICONE (3000011022) | |||
| CETRIMIDE (1000006286) | |||
| SALICYLIC ACID (1000009710) | |||
| ICHTHAMMOL (1000008905) | |||
| DIAZEPAM (1000003208) | |||
| SIMETHICONE (1000009128) | |||
| POLYMYXIN B SULPHATE (4000010173) | |||
| ASPIRIN (1000009870) | |||
| APIXABAN (1000011644) | |||
| LOFEPRAMINE HYDROCHLORIDE (2000008496) | |||
| METHYL SALICYLATE (1000000149) | |||
| CHLORHEXIDINE DIHYDROCHLORIDE (4000002466) | |||
| NYSTATIN (1000009661) | |||
| SODIUM CHLORIDE (1000009536) | |||
| UREA (1000009262) | |||
| CHLORHEXIDINE GLUCONATE SOLUTION 20% (4000003482) | |||
| LOPERAMIDE HYDROCHLORIDE (2000008494) | |||
| AMANTADINE SULPHATE (2000019040) | |||
| INDAPAMIDE (1000008739) | |||
| LORAZEPAM (1000008543) | |||
| PENICILLIN V POTASSIUM (4000007429) | |||
| EPINEPHRINE (1000009945) | |||
| DOXYLAMINE SUCCINATE (2000007681) | |||
| BENZALKONIUM CHLORIDE (2000010983) | |||
| CHLORDIAZEPOXIDE HYDROCHLORIDE (2000008104) | |||
| CODEINE PHOSPHATE HEMIHYDRATE (4000006570) | |||
| PENICILLIN V CALCIUM (4000014135) | |||
| MEBEVERINE (1000000255) | |||
| PROCAINE HYDROCHLORIDE (2000007906) | |||
| CHLORHEXIDINE DIACETATE (4000007351) | |||
| CARVEDILOL (1000003761) | |||
| BISOPROLOL FUMARATE (2000008290) | |||