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

Registrant Details
1. Registration NumberUK API 49402
2. Name or corporate name of registrantAZELIS 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
6. Name of responsible officer of the competent authority of the member state validating the registration Confidential
7. Date 26/06/2024

 

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

Name and address of the site

AZELIS UK LIMITED, FOXHOLES BUSINESS PARK, JOHN TATE ROAD, HERTFORD, SG13 7YH, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
Active Substance 3rd Country Manufacturer 3rd Country Distributor
PHENOBARBITONE (3000014222)

NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 9 XINGTAI ROAD, ZONE GANGZHA, ECONOMIC DEVELOPMENT, NANTONG, JIANGSU, CN-226005, CHINA

CLOPIDOGREL BESILATE (2000013668)

CADILA HEALTHCARE LIMITED, ZYDUS TOWER, 5TH FLOOR-SATELLITE CROSS ROADS, SARKHEJ ROAD, GANDHINAGAR, GUJARAT, IN-380015, INDIA

LISINOPRIL DIHYDRATE (2000008500)

ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA

MAGNESIUM HYDROXIDE (1000000894)

SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES

PHENYLBUTAZONE (1000009893)

NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 43 YAOGANG ROAD, NANTONG, JIANGSU PROVINCE, CN-226 006, CHINA

BENZYL NICOTINATE (1000009481)

HERBERT BROWN PHARMACEUTICAL AND RESEARCH LABORATORIES, W-256-A, MIDC PHASE II, SHIVAJI UDYOG NAGAR, DOMBIVLI, THANE, IN-421203, INDIA

PSEUDOEPHEDRINE HYDROCHLORIDE (2000007829)

EMBIO LIMITED, 501 SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI, IN-400 076, INDIA

IBUPROFEN (1000008918)

SI GROUP, 725 CANNON BRIDGE ROAD, ORANGEBURG, 29115, UNITED STATES

PHENOBARBITAL (1000014071)

NANTONG JINGHUA PHARMACEUTICAL COMPANY LIMITED, 9 XINGTAI ROAD, ZONE GANGZHA, ECONOMIC DEVELOPMENT, NANTONG, JIANGSU, CN-226005, CHINA

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

MOMETASONE FUROATE (2000008125)

AURISCO PHARMACEUTICAL LIMITED, ROOM 1709-1710 HITECH PLAZA, NO 488 S WU NING ROAD, SHANGHAI, CN-200 042, CHINA

MAGALDRATE (1000001270)

SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES

PARACETAMOL (1000009609)

NOVACYL (WUXI) PHARMACEUTICAL COMPANY LIMITED, 16 GUANGSHI ROAD, MEIJING VILLAGE, LUOSHE TOWN, HUISHAN DISTRICT, WUXI, JIANGSU PROVINCE, CN-214185, CHINA

ANQIU LU'AN PHARMACEUTICAL COMPANY LIMITED, 35 WEIXU NORTH ROAD, ANQIU CITY, SHANDONG PROVINCE, CN-262 100, CHINA

ENALAPRIL MALEATE (2000007672)

ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA

GRANISETRON (1000009464)

CIPLA LIMITED, MANUFACTURING & RESEARCH DIVISION, OLD MADRAS ROAD, VIRGONAGAR DISTRICT, BANGALORE, KARNATAKA, IN-560 049, INDIA

EPHEDRINE HYDROCHLORIDE (2000007671)

EMBIO LIMITED, 501 SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI, IN-400 076, INDIA

PERINDOPRIL ERBUMINE (2000008381)

GLENMARK, PLOT NO. 3109- C, GIDC INDUSTRIAL ESTATE, ANKLESHWAR, DIST. BHARUCH, GUJARAT STATE, IN-393 002, INDIA

CAPTOPRIL (1000006787)

ZHEJIANG HUAHAI PHARMACEUTICAL CO LIMITED, XUNQIAO, LINHAI CITY, ZHEJIANG PROVINCE, CN-317024, CHINA

NOSCAPINE (1000009663)

ALKALOIDS CORPORATION, 8 BENTINCK STREET, KOLKATA, IN-700 001, INDIA

ALUMINIUM HYDROXIDE (1000013126)

SPI PHARMA, INC, 503 CARR ROAD, WILMINGTON, 19809, UNITED STATES

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
PENICILLIN V CALCIUM (4000014135)
AMANTADINE SULPHATE (2000019040)
APIXABAN (1000011644)
POLYMYXIN B SULPHATE (4000010173)
ICHTHAMMOL (1000008905)
BISOPROLOL FUMARATE (2000008290)
EPINEPHRINE (1000009945)
SODIUM CHLORIDE (1000009536)
CHLORHEXIDINE GLUCONATE SOLUTION 20% (4000003482)
ASPIRIN (1000009870)
DIMETHICONE (3000011022)
CARVEDILOL (1000003761)
METHYL SALICYLATE (1000000149)
UREA (1000009262)
PROCAINE HYDROCHLORIDE (2000007906)
MEBEVERINE (1000000255)
LOFEPRAMINE HYDROCHLORIDE (2000008496)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)
CETRIMIDE (1000006286)
CHLORDIAZEPOXIDE HYDROCHLORIDE (2000008104)
LORAZEPAM (1000008543)
CHLORHEXIDINE DIHYDROCHLORIDE (4000002466)
SIMETHICONE (1000009128)
DIAZEPAM (1000003208)
SALICYLIC ACID (1000009710)
DOXYLAMINE SUCCINATE (2000007681)
NYSTATIN (1000009661)
PENICILLIN V POTASSIUM (4000007429)
BENZALKONIUM CHLORIDE (2000010983)
CHLORHEXIDINE DIACETATE (4000007351)
LOPERAMIDE HYDROCHLORIDE (2000008494)