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 14023 |
| 2. Name or corporate name of registrant | CATALENT UK SWINDON ZYDIS LIMITED |
| 3. Permanent or legal address of registrant | CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, 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 | 09/10/2024 |
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
CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| ARIPIPRAZOLE (1000000123) | OTSUKA PHARMACEUTICAL COMPANY LIMITED, 224-18, HIRASHI EBISUNO, KAWAUCHI-CHO, TOKUSHIMA, JP-771-0182, JAPAN OTSUKA SAGA FACTORY, 5006-5, AZAHIGASHIYAMA, OMAGARI, KANZAKI-GUN, YOSHINOGARI-CHO, SAGA, JP-842-0197, JAPAN |
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| LOPERAMIDE HYDROCHLORIDE (2000008494) | VASUDHA PHARMA CHEM LIMITED, UNIT-II, PLOT NO. 79, JAWAHARLAL NEHRU PHARMA CITY, THANAM, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN-531019, INDIA |
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| SCOPOLAMINE HYDROBROMIDE (4000007162) | ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, 10-50 FURUKAWACHO MUKAIMACHI NICHOME, HIDA, GIFU, JP-509 4241, JAPAN |
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| LORATADINE HYDROCHLORIDE (2000017674) | MYLAN LABORATORIES LIMITED, (UNIT 7), PLOT NO. 14, 99 & 100, I.D.A, PASHAMYLARAM PHASE II, Data Not Available, PATANCHERU,TELANGANA, IN-502 307, INDIA VASUDHA PHARMA CHEM LIMITED, UNIT-II, PLOT NO. 79, JAWAHARLAL NEHRU PHARMA CITY, THANAM, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN-531019, INDIA |
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| RIMEGEPANT (3000020812) | ANTHEM BIOSCIENCES PVT LIMITED, UNIT II NO. 276-P AND 277-P, 20 BANNIKUPPE ROAD, HAROHALLI INDUSTRIAL AREA PHASE II, KANAKPURA TALUK, RAMANAGARA, KARNATAKA, IN-562112, INDIA ANTHEM BIOSCIENCES PVT LIMITED, NO 49, F1 & F2 CANARA BANK ROAD, BOMMASANDRA INDUSTRIAL AREA, PHASE 1, HOSUR ROAD, BENGALURU, KARNATAKA, IN-560 099, INDIA ESCIENTIA ADVANCED SCIENCES PRIVATE LIMITED, PLOT NO. 11, 11A, 12 AND 12A, APSEZ ATCHUTAPURAM, ANAKAPALLI DISTRICT, VISAKHAPATNAM, ANDHRA PRADESH, IN-531011, INDIA PIRAMAL PHARMA LIMITED, SURVEY NOS. 7-70, 70/1 AND 70/2, DIGWAL VILLAGE, KOHIR MANDAL, KOHIR CROSS ROAD, SANGAREDDY DISTRICT, TELANGANA, IN-502 321, INDIA |
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| OLANZAPINE (1000007944) | LONZA MONTEGGIO, VIA CANTONALE 4, MONTEGGIO, CH-6998, SWITZERLAND |
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| CRYPTOMERIA JAPONICA (2000018035) | KNC LABORATORIES COMPANY LIMITED, KNC BIO-RESEARCH CENTER, 1-1-1 MUROTANI, NISHI-KU, KOBE, HYOGO, JP 651-2241, JAPAN |
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| RIZATRIPTAN BENZOATE (2000007163) | AUROBINDO PHARMA LIMITED, UNIT XI, SURVEY NOS. 61-66, INDUSTRIAL DEVELOPMENT AREA, PYDIBHIMAVARAM, RANASTHALAM MANDAL, SRIKAKULAM DISTRICT, ANDHRA PRADESH, IN-532409, INDIA |
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| DOMPERIDONE (1000002907) | VASUDHA PHARMA CHEM LIMITED, UNIT-II, PLOT NO. 79, JAWAHARLAL NEHRU PHARMA CITY, THANAM, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN-531019, INDIA |
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| ONDANSETRON (1000009100) | GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE |
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| CHLORPHENIRAMINE MALEATE (2000008095) | KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA CITY, TOYAMA, JP 930-0912, JAPAN |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| RIMEGEPANT (3000020812) | |||