Download PDF

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 1108
2. Name or corporate name of registrantMACFARLAN SMITH LIMITED
3. Permanent or legal address of registrant MACFARLAN SMITH LIMITED, 10 WHEATFIELD ROAD, EDINBURGH, EH11 2QA, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

MACFARLAN SMITH LIMITED, 10 WHEATFIELD ROAD, EDINBURGH, EH11 2QA, UNITED KINGDOM

MACFARLAN SMITH LIMITED, THREE TREES ROAD, NEWBIE, ANNAN, DG12 5QH, 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 06/12/2023

 

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

Name and address of the site

MACFARLAN SMITH LIMITED, 10 WHEATFIELD ROAD, EDINBURGH, EH11 2QA, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
FENTANYL CITRATE
2000007584
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
CODEINE SULFATE
2000015376
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
SUFENTANIL CITRATE
2000006818
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Sieving
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
HYDROMORPHONE HYDROCHLORIDE
2000007868
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
OXYCODONE
1000007438
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crytsallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying and milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
MORPHINE HYDROCHLORIDE
2000008247
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
APOMORPHINE HYDROCHLORIDE
2000008051
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt Formation, Filtration, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
METHYLPHENIDATE HYDROCHLORIDE
2000008305
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
COCAINE
1000003943
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
DIAMORPHINE HYDROCHLORIDE
2000007776
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt Formation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
REMIFENTANIL HYDROCHLORIDE
2000007435
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt Formation, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Sieving
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
NALOXONE HYDROCHLORIDE
2000008238
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
BUPRENORPHINE HYDROCHLORIDE
2000008277
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt Formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
MORPHINE SULFATE
4000006163
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
DIAMORPHINE
1000003221
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
ALFENTANIL HYDROCHLORIDE
2000008540
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt Formation, Filtration, Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Sieving
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
FENTANYL
1000002290
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
DIHYDROCODEINE HYDROGEN TARTRATE
4000008052
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
COCAINE HYDROCHLORIDE
2000007943
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
CODEINE
1000003912
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying and milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
MORPHINE
1000010779
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
MORPHINE TARTRATE
2000008245
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
CODEINE PHOSPHATE HEMIHYDRATE
4000006570
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
BUPRENORPHINE
1000007171
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
OXYCODONE HYDROCHLORIDE
2000006722
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
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
PHOLCODINE
1000009886
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
FENTANYL CITRATE (2000007584)
CODEINE SULFATE (2000015376)
SUFENTANIL CITRATE (2000006818)
HYDROMORPHONE HYDROCHLORIDE (2000007868)
OXYCODONE (1000007438)
MORPHINE HYDROCHLORIDE (2000008247)
APOMORPHINE HYDROCHLORIDE (2000008051)
METHYLPHENIDATE HYDROCHLORIDE (2000008305)
COCAINE (1000003943)
DIAMORPHINE HYDROCHLORIDE (2000007776)
REMIFENTANIL HYDROCHLORIDE (2000007435)
NALOXONE HYDROCHLORIDE (2000008238)
BUPRENORPHINE HYDROCHLORIDE (2000008277)
MORPHINE SULFATE (4000006163)
DIAMORPHINE (1000003221)
ALFENTANIL HYDROCHLORIDE (2000008540)
FENTANYL (1000002290)
DIHYDROCODEINE HYDROGEN TARTRATE (4000008052)
COCAINE HYDROCHLORIDE (2000007943)
CODEINE (1000003912)
MORPHINE (1000010779)
MORPHINE TARTRATE (2000008245)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)
BUPRENORPHINE (1000007171)
OXYCODONE HYDROCHLORIDE (2000006722)
PHOLCODINE (1000009886)
Name and address of the site

MACFARLAN SMITH LIMITED, THREE TREES ROAD, NEWBIE, ANNAN, DG12 5QH, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
METHYLPHENIDATE HYDROCHLORIDE
2000008305
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
OXYCODONE HYDROCHLORIDE
2000006722
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
BUPRENORPHINE
1000007171
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.4 Other
Hydrogenation
E General Finishing Steps
E.4 Other
This intermediate supplied to Edinburgh site for further processing as an API
F Quality Control Testing
F.1 Physical / Chemical testing
Other Activities
Only intermediate specification testing
Active substance
DIHYDROCODEINE HYDROGEN TARTRATE
4000008052
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
CODEINE PHOSPHATE HEMIHYDRATE
4000006570
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Salt formation, Crystallisation.
E General Finishing Steps
E.1 Physical Processing Steps
Drying, Milling
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
METHYLPHENIDATE HYDROCHLORIDE (2000008305)
OXYCODONE HYDROCHLORIDE (2000006722)
DIHYDROCODEINE HYDROGEN TARTRATE (4000008052)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)

Download PDF