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 4351 |
| 2. Name or corporate name of registrant | PENN PHARMACEUTICAL SERVICES LIMITED |
| 3. Permanent or legal address of registrant | PENN PHARMACEUTICAL SERVICES LIMITED, UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, NP22 3AA, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
PENN PHARMACEUTICAL SERVICES LIMITED, UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, NP22 3AA, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 03/06/2024 |
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
PENN PHARMACEUTICAL SERVICES LIMITED, UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, NP22 3AA, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| POMALIDOMIDE (1000016945) | CARBOGEN AMCIS, HAUPTSTRASSE 171, BUBENDORF, CH-4416, SWITZERLAND |
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| MENADIOL DIPHOSPHATE (2000020237) | API INCORPORATED, 10 INDUSTRIAL ROAD, FAIRFIELD, 07004, UNITED STATES SHANGHAI WANSU PHARMACEUTICAL CO, NO DATA HELD, Data Not Available, Data Not Available, JAPAN |
||
| ISOCARBOXAZID (1000008028) | API INCORPORATED, 10 INDUSTRIAL ROAD, FAIRFIELD, 07004, UNITED STATES SHANGHAI WANSU PHARMACEUTICAL CO, NO DATA HELD, Data Not Available, Data Not Available, JAPAN |
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| IBANDRONATE MONOSODIUM MONOHYDRATE (4000014459) | F. HOFFMANN-LA ROCHE LIMITED, GRENZACHERSTRASSE 124, BASEL, CH-4070, SWITZERLAND |
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| MACITENTAN MICRONISED (2000018968) | LONZA AG, ROTTENSTRASSE 6, VISP, CH-3930, SWITZERLAND |
LONZA AG, ROTTENSTRASSE 6, VISP, CH-3930, SWITZERLAND |
|
| ONDANSETRON (1000009100) | PLOT NO. D-7, M.I.D.C. INDUSTRIAL AREA, PLOT NO. D-7, M.I.D.C. INDUSTRIAL AREA, KURKUMBH VILLAGE, TALUKA DAUND, DISTRICT PUNE, IN 413802, INDIA |
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| TEMOZOLOMIDE (1000002416) | FORMOSA LABORATORIES INC, 36 HOPING STREET, LOUCHU TOWNSHIP, TAOYUAN COUNTY, TW 33842, TAIWAN |
FORMOSA LABORATORIES INC, 36 HOPING STREET, LOUCHU TOWNSHIP, TAOYUAN COUNTY, TW 33842, TAIWAN |
|
| VANDETANIB (1000011523) | LONZA AG, LONZASTRASSE 2, VISP, CH-3930, SWITZERLAND |
LONZA AG, LONZASTRASSE 2, VISP, CH-3930, SWITZERLAND |
|
| THALIDOMIDE (1000007423) | SIEGFRIED AG, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
SIEGFRIED AG, UNTERE BRUEHLSTRASSE 4, ZOFINGEN, CH-4800, SWITZERLAND |
|
| TADALAFIL (1000000162) | SMS PHARMACEUTICALS LIMITED, UNIT II PLOT NO. 24 AND 24B, SV.CO-OPERATIVE INDUSTRIAL ESTATE, BACHUPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500 090, INDIA |
SMS PHARMACEUTICALS LIMITED, UNIT II PLOT NO. 24 AND 24B, SV.CO-OPERATIVE INDUSTRIAL ESTATE, BACHUPALLY, MEDCHAL-MALKAJGIRI DISTRICT, HYDERABAD, TELANGANA, IN-500 090, INDIA |
|
| IBANDRONATE (3000022303) | MAPRIMED SA, CORONEL PRUDENCIO MURGUIONDO 2011, BUENOS AIRES, AR-1440, ARGENTINA |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| THALIDOMIDE (1000007423) | |||