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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

Registrant Details
1. Registration NumberUK API 28255
2. Name or corporate name of registrantRUTLAND 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

Name and address of the site

RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
SCUTELLARIA LATERIFLORA
2000012996
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)
Active substance
HYPERICUM PERFORATUM
2000011927
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)
Active substance
DRIMIA INDICA
1000007667
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)
Active substance
PASSIFLORA INCARNATA
2000012458
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)
Active substance
FUCUS VESICULOSUS
2000011728
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)
Active substance
GUAREA RUSBYI
2000011388
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)
Active substance
BELLADONNA TINCTURE
2000008372
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)
Active substance
MELISSA OFFICINALIS QUANTIFIED DRY EXTRACT
4000011423
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)
Active substance
EPHEDRINE
1000002754
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)
Active substance
LIQUIFIED PHENOL
2000008503
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)
Active substance
TOLU FLAVOUR
1000004861
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)
Active substance
COAL TAR SOLUTION
2000011380
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)
Active substance
POLYGALA SENEGA ROOT
4000014427
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)
Active substance
COAL TAR SOLUTION STRONG
4000014216
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)
Active substance
MATRICARIA CHAMOMILLA FLOWERS
4000014429
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)
Active substance
BOSWELLIA SERRATA EXTRACT
1000019859
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)
Active substance
CHLOROFORM AND MORPHINE TINCTURE
3000004780
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)
Active substance
INULA HELENIUM ROOT
4000014425
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)
Active substance
ECHINACEA
1000006672
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)
Active substance
LOBELIA INFLATA
1000007633
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)
Active substance
VERBENA OFFICINALIS HERB
4000014428
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)
Active substance
GLYCYRRHIZA GLABRA ROOT
4000013679
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)
Active substance
TOLU-FLAVOUR SOLUTION
2000004001
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)
Active substance
ARCTIUM LAPPA ROOT
4000014422
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)
Active substance
TOLU BALSAM SYRUP
1000009310
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)
Active substance
RHEUM PALMATUM
2000012870
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)
Active substance
COCILLANA EXTRACT
4000009543
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)
Active substance
CIMICIFUGA RACEMOSA
2000011320
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)
Active substance
COMMIPHORA MYRRHA RESIN
4000014423
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)
Active substance
MARRUBIUM VULGARE HERB
4000014430
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)
Active substance
BAPTISIA TINCTORIA
1000006597
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)
Active substance
TOLU BALSAM SOLUTION
4000010509
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)
Active substance
FUMARIA OFFICINALIS HERB
4000014424
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)
Active substance
VITEX AGNUS-CASTUS FRUIT
4000014432
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)
Active substance
HYSSOPUS OFFICINALIS HERB
3000018457
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)
Active substance
CAMPHORATED OPIUM TINCTURE
1000006847
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)
Active substance
PREPARED COAL TAR
2000007910
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)
Active substance
OPIUM TINCTURE
2000008161
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)
Active substance
TOLU BALSAM TINCTURE
4000010511
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)
Active substance
COCILLANA LIQUID EXTRACT
4000009545
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)
Active substance
AVENA SATIVA
1000009783
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)
Active substance
THYMUS SERPYLLUM HERB
4000014431
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)
Active substance
PAEONIA LACTIFLORA UNPEELED ROOT
4000014426
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)
Active substance
ANISE OIL
4000010114
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)
Active substance
CARAPICHEA IPECACUANHA ROOT
2000017650
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)
Active substance
VALERIANA OFFICINALIS ROOT
2000016573
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)

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