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 32496 |
| 2. Name or corporate name of registrant | AESICA QUEENBOROUGH LIMITED |
| 3. Permanent or legal address of registrant | AESICA QUEENBOROUGH LIMITED, NORTH ROAD, QUEENBOROUGH, ME11 5EL, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
AESICA QUEENBOROUGH LIMITED, NORTH ROAD, QUEENBOROUGH, ME11 5EL, 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 | 08/08/2023 |
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
AESICA QUEENBOROUGH LIMITED, NORTH ROAD, QUEENBOROUGH, ME11 5EL, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CLARITHROMYCIN (1000009509) | ZHEJIAN GUOBANG PHARMA CO, LIMITED., NO. 6 WEIWU ROAD, HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANGYU, ZHEJIANG, CN-312 369, CHINA |
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| TERAZOSIN HYDROCHLORIDE (2000007384) | ASSIA CHEMICAL INDUSTRIES LIMITED, TEVA-TECH SITE, TEVA TECH SITE, NEOT-HOVAV ECO-INDUSTRIAL PARK, EMEK SARA, BE'ER SHEVA, IL-8412316, ISRAEL |
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| ISOFLURANE (1000007817) | SHANDONG NEW TIME PHARMACEUTICAL COMPANY LIMITED, NO.1 NORTH OUTER RING ROAD, FEIXIAN COUNTY, LINYI, SHANDONG, CN-273 400, CHINA |
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| SEVOFLURANE (1000002676) | CENTRAL GLASS CO., LIMITED. - UBE PLANT, 5253 OAZA OKIUBE, UBE CITY, YAMAGUCHI PREFECTURE, JP-755-0001, JAPAN HALOCARBON LIFE SCIENCES, LLC, 1100 DITTMAN COURT, NORTH AUGUSTA, 29841, UNITED STATES SHANDONG NEW TIME PHARMACEUTICAL COMPANY LIMITED, NO.1 NORTH OUTER RING ROAD, FEIXIAN COUNTY, LINYI, SHANDONG, CN-273 400, CHINA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| NALTREXONE BASE ANHYDROUS (3000013154) | |||