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 33656 |
| 2. Name or corporate name of registrant | VIFOR PHARMA UK LIMITED |
| 3. Permanent or legal address of registrant | VIFOR PHARMA UK LIMITED, THE OLD STABLES, BAGSHOT PARK, BAGSHOT, GU19 5PJ, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
VIFOR PHARMA UK LIMITED - POTTERS DIVISION, 1 BOTANIC COURT, MARTLAND PARK, WIGAN, WN5 0JZ, 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 | 11/11/2015 |
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
VIFOR PHARMA UK LIMITED - POTTERS DIVISION, 1 BOTANIC COURT, MARTLAND PARK, WIGAN, WN5 0JZ, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
Active substance
HOREHOUND EXTRACT
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
VERVAIN EXTRACT
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
BURDOCK ROOT DRY EXTRACT
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
BLUE FLAG DRY EXTRACT 3:1 CONCENTRATE
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
BURDOCK ROOT LIQUID EXTRACT 1:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
BONESET LIQUID EXTRACT 1:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
PASSION FLOWER DRY EXTRACT 5:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
CLIVERS DRY EXTRACT 4:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
ELECAMPANE ROOT EXTRACT
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
CLIVERS LIQUID EXTRACT 1:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
HYSSOP LIQUID EXTRACT 1:1
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
Active substance
ECHINACEA ANGUSTIFOLIA
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
Drying and Milling | |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| SLIPPERY ELM BARK (4000010549) | AMERICAN BOTANICALS, PO BOX 158, 24750 HIGHWAY FF, EOLIA, 63344, UNITED STATES |
||
| BUTTERNUT BARK POWDER (4000013740) | NATUREX INCORPORATED, 375 HUYLER STREET, SOUTH HACKENSACK, 07606, UNITED STATES |
||
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| HOPS (3000007607) | |||
| SHEPHERDS PURSE (3000008876) | |||
| HOREHOUND EXTRACT (2000013898) | |||
| SENEGA ROOT (4000010159) | |||
| BOLDO DRY EXTRACT (2000006029) | |||
| COUCH-GRASS (3000007472) | |||
| PRICKLY ASH BARK (2000005765) | |||
| CASCARA BARK (4000010238) | |||
| BURDOCK ROOT DRY EXTRACT (4000013164) | |||
| WILD INDIGO LIQUID EXTRACT 1:1 45% ALCOHOL (4000002664) | |||
| HEMLOCK SPRUCE BARK LIQUID EXTRACT 1:1 (4000002243) | |||
| SKULLCAP (3000010128) | |||
| SENNA PODS POWDERED (4000002377) | |||
| JAMAICA DOGWOOD (3000004704) | |||
| BURDOCK ROOT LIQUID EXTRACT 1:1 (4000013167) | |||
| LOBELIA (3000004265) | |||
| ALOES POWDERED (3000016703) | |||
| BONESET LIQUID EXTRACT 1:1 (4000002932) | |||
| SENNA LEAF (4000010337) | |||
| WILD CARROT (3000010502) | |||
| CLIVERS DRY EXTRACT 4:1 (4000013288) | |||
| BUCKTHORN BARK (2000017181) | |||
| DANDELION ROOT POWDER (2000007856) | |||
| ELECAMPANE ROOT EXTRACT (4000014124) | |||
| CLIVERS LIQUID EXTRACT 1:1 (4000013290) | |||
| BAYBERRY BARK LIQUID EXTRACT 1:1 (4000002934) | |||
| HYSSOP LIQUID EXTRACT 1:1 (2000006421) | |||
| ACETUM SCILLAE (4000003385) | |||
| UVA URSI DRY EXTRACT (4000002992) | |||
| IPECAC (3000003474) | |||
| FENNEL SEED POWDER (2000016578) | |||
| ECHINACEA EXTRACT (2000007676) | |||
| PASSIFLORA (1000013999) | |||
| PLEURISY ROOT LIQUID EXTRACT 1:1 35% ALCOHOL (4000002778) | |||
| VALERIAN EXTRACT (2000008486) | |||
| YARROW POWDERED HERB (4000009192) | |||
| ELDER FLOWER HERB, POWDERED (2000016615) | |||