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 20075 |
| 2. Name or corporate name of registrant | ACCORD HEALTHCARE LIMITED |
| 3. Permanent or legal address of registrant | ACCORD HEALTHCARE LIMITED, GROUND FLOOR, SAGE HOUSE, 319 PINNER ROAD, HARROW, HA1 4HF, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
ACCORD HEALTHCARE LIMITED, EDGEFIELD AVENUE, NEWCASTLE UPON TYNE, NE3 3NB, 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 | 18/10/2024 |
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
ACCORD HEALTHCARE LIMITED, EDGEFIELD AVENUE, NEWCASTLE UPON TYNE, NE3 3NB, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| TRAMADOL HYDROCHLORIDE (2000008034) | WANBURY LIMITED, 10TH FLOOR, B-WING, BSEL TECH PARK, SECTOR 30A, OPPOSITE VASHI RAILWAY STATION, VASHI, NAVI MUMBAI, MAHARASHTRA, IN-400 703, INDIA |
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| PARACETAMOL (1000009609) | FARMSON PHARMACEUTICAL GUJARAT PVT. LIMITED., PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA ATABAY KIMYA SANAYI VE TICARET AS, ACIBADEM, KOFTUNCU SOKAK NO. 1, KADIKOY, ISTANBUL, TR-81010, TURKEY |
ATABAY KIMYA SANAYI VE TICARET AS, ACIBADEM, KOFTUNCU SOKAK NO. 1, KADIKOY, ISTANBUL, TR-81010, TURKEY FARMSON PHARMACEUTICAL GUJARAT PVT. LIMITED., PLOT NO. 14 GIDC INDUSTRIAL ESTATE, NANDESARI, VADODARA DISTRICT, GUJARAT, IN-391340, INDIA |
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| CODEINE PHOSPHATE (2000007940) | ALCALIBER SA, AVENIDA DEL RIO VENTALOMAR 1, POLIGONO MARIA DE BENQUERENCIA, TOLEDO, E-45007, SPAIN |
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| CAFFEINE (1000007507) | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH, KARLSTRASSE 15, MINDEN, D-32423, GERMANY |
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| RANITIDINE HYDROCHLORIDE (2000007813) | SARACA LABORATORIES LIMITED, PLOT NO. 320, EAST AVENUE, 1ST FLOOR, SWAMY AYYAPPA HOUSING SOCIETY LTD, MADHAPUR, HYDERABAD, TELANGANA, IN 500081, INDIA |
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| ALENDRONIC ACID (1000002993) | IPCA, P.O. SEJAVATA, RATLAM, MADHYA PRADESH, IN-457002, INDIA |
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