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 14023
2. Name or corporate name of registrantCATALENT 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
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

Name and address of the site

CATALENT UK SWINDON ZYDIS LIMITED, FRANKLAND ROAD, BLAGROVE, SWINDON, SN5 8RU, UNITED KINGDOM

2. IMPORTATION AND DISTRIBUTION OPERATIONS
AImportation
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

LOPERAMIDE HYDROCHLORIDE (2000008494)

VASUDHA PHARMA CHEM LIMITED, UNIT-II, PLOT NO. 79, JAWAHARLAL NEHRU PHARMA CITY, THANAM, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN-531019, INDIA

SCOPOLAMINE HYDROBROMIDE (4000007162)

ALPS PHARMACEUTICAL INDUSTRIES COMPANY LIMITED, 10-50 FURUKAWACHO MUKAIMACHI NICHOME, HIDA, GIFU, JP-509 4241, JAPAN

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

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

OLANZAPINE (1000007944)

LONZA MONTEGGIO, VIA CANTONALE 4, MONTEGGIO, CH-6998, SWITZERLAND

CRYPTOMERIA JAPONICA (2000018035)

KNC LABORATORIES COMPANY LIMITED, KNC BIO-RESEARCH CENTER, 1-1-1 MUROTANI, NISHI-KU, KOBE, HYOGO, JP 651-2241, JAPAN

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

DOMPERIDONE (1000002907)

VASUDHA PHARMA CHEM LIMITED, UNIT-II, PLOT NO. 79, JAWAHARLAL NEHRU PHARMA CITY, THANAM, PARAWADA, ANAKAPALLI, ANDHRA PRADESH, IN-531019, INDIA

ONDANSETRON (1000009100)

GLAXO WELLCOME MANUFACTURING PTE LIMITED, 1 PIONEER SECTOR 1, JURONG, SINGAPORE, SG-628413, SINGAPORE

CHLORPHENIRAMINE MALEATE (2000008095)

KONGO CHEMICAL COMPANY LIMITED, NO 3 HIMATA, TOYAMA CITY, TOYAMA, JP 930-0912, JAPAN

2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
RIMEGEPANT (3000020812)