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 1811 |
| 2. Name or corporate name of registrant | BARD PHARMACEUTICALS LIMITED |
| 3. Permanent or legal address of registrant | BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, 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 | 12/06/2023 |
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
BARD PHARMACEUTICALS LIMITED, UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, UNITED KINGDOM
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| TRAMADOL HYDROCHLORIDE (2000008034) | WAVELENGTH PHARMACEUTICALS LIMITED, NEOT HOVAV ECO INDUSTRIAL PARK, P.O.BOX 3593, BEER SHEVA, IL-8413502, ISRAEL |
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| OXYCODONE HYDROCHLORIDE (2000006722) | NORAMCO INCORPORATED, 500 SWEDES LANDING ROAD, WILMINGTON, 19801-4417, UNITED STATES |
||
| HYDROMORPHONE HYDROCHLORIDE (2000007868) | NORAMCO INCORPORATED, 500 SWEDES LANDING ROAD, WILMINGTON, 19801-4417, UNITED STATES |
||
| NALOXONE HYDROCHLORIDE (2000008238) | NORAMCO INCORPORATED, 500 SWEDES LANDING ROAD, WILMINGTON, 19801-4417, UNITED STATES |
NORAMCO INCORPORATED, 500 SWEDES LANDING ROAD, WILMINGTON, 19801-4417, UNITED STATES |
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| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| OXYCODONE HYDROCHLORIDE (2000006722) | |||