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 28255 |
2. Name or corporate name of registrant | RUTLAND BIODYNAMICS LIMITED |
3. Permanent or legal address of registrant | RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, UNITED KINGDOM |
4. Address(es) of site(s) where registered activities take place |
RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, 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 | 17/04/2024 |
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
RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
E | General Finishing Steps |
E.1 Physical Processing Steps
Mix Phenol and water. Adjust to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
E | General Finishing Steps |
E.1 Physical Processing Steps
Mix Phenol and water. Adjust to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
E | General Finishing Steps |
E.1 Physical Processing Steps
Mix Phenol and water. Adjust to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.4 Mineral Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.4 Mineral Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
B.5 Modification of Extracted Substance | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
B.5 Modification of Extracted Substance | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
B.5 Modification of Extracted Substance | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.4 Mineral Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
B.5 Modification of Extracted Substance | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Solvation | |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.2 Primary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
B | Extraction of Active Substance from Natural Sources |
B.1 Plant Source Extraction | |
E | General Finishing Steps |
E.1 Physical Processing Steps
Adjustment to final specification | |
E.2 Primary Packaging | |
E.3 Secondary Packaging | |
F | Quality Control Testing |
F.1 Physical / Chemical testing | |
F.2 Microbiological testing (excluding sterility testing) |
2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
B | Distribution | ||
SCUTELLARIA LATERIFLORA (2000012996) | |||
HYPERICUM PERFORATUM (2000011927) | |||
DRIMIA INDICA (1000007667) | |||
PASSIFLORA INCARNATA (2000012458) | |||
FUCUS VESICULOSUS (2000011728) | |||
GUAREA RUSBYI (2000011388) | |||
BELLADONNA TINCTURE (2000008372) | |||
MELISSA OFFICINALIS QUANTIFIED DRY EXTRACT (4000011423) | |||
EPHEDRINE (1000002754) | |||
LIQUIFIED PHENOL (2000008503) | |||
TOLU FLAVOUR (1000004861) | |||
COAL TAR SOLUTION (2000011380) | |||
POLYGALA SENEGA ROOT (4000014427) | |||
COAL TAR SOLUTION STRONG (4000014216) | |||
MATRICARIA CHAMOMILLA FLOWERS (4000014429) | |||
BOSWELLIA SERRATA EXTRACT (1000019859) | |||
CHLOROFORM AND MORPHINE TINCTURE (3000004780) | |||
INULA HELENIUM ROOT (4000014425) | |||
ECHINACEA (1000006672) | |||
LOBELIA INFLATA (1000007633) | |||
VERBENA OFFICINALIS HERB (4000014428) | |||
GLYCYRRHIZA GLABRA ROOT (4000013679) | |||
TOLU-FLAVOUR SOLUTION (2000004001) | |||
ARCTIUM LAPPA ROOT (4000014422) | |||
TOLU BALSAM SYRUP (1000009310) | |||
RHEUM PALMATUM (2000012870) | |||
COCILLANA EXTRACT (4000009543) | |||
CIMICIFUGA RACEMOSA (2000011320) | |||
COMMIPHORA MYRRHA RESIN (4000014423) | |||
MARRUBIUM VULGARE HERB (4000014430) | |||
BAPTISIA TINCTORIA (1000006597) | |||
TOLU BALSAM SOLUTION (4000010509) | |||
FUMARIA OFFICINALIS HERB (4000014424) | |||
VITEX AGNUS-CASTUS FRUIT (4000014432) | |||
HYSSOPUS OFFICINALIS HERB (3000018457) | |||
CAMPHORATED OPIUM TINCTURE (1000006847) | |||
PREPARED COAL TAR (2000007910) | |||
OPIUM TINCTURE (2000008161) | |||
TOLU BALSAM TINCTURE (4000010511) | |||
COCILLANA LIQUID EXTRACT (4000009545) | |||
AVENA SATIVA (1000009783) | |||
THYMUS SERPYLLUM HERB (4000014431) | |||
PAEONIA LACTIFLORA UNPEELED ROOT (4000014426) | |||
ANISE OIL (4000010114) | |||
CARAPICHEA IPECACUANHA ROOT (2000017650) | |||
VALERIANA OFFICINALIS ROOT (2000016573) |