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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 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
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 20/01/2025

 

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
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
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
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
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 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
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
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
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
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
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
5-OXO-5-[PHENYL[1-(2-PHENYLETHYL)-4-PIPERIDINYL] AMINO] PENTANOIC ACID
1000022901
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, filtration and recrystallisation
E General Finishing Steps
E.1 Physical Processing Steps
Drying
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
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
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
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
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
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
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
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
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
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
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
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
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)
2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
FENTANYL (1000002290)
MORPHINE HYDROCHLORIDE (2000008247)
OXYCODONE HYDROCHLORIDE (2000006722)
DIHYDROCODEINE HYDROGEN TARTRATE (4000008052)
CODEINE SULFATE (2000015376)
DIAMORPHINE HYDROCHLORIDE (2000007776)
ALFENTANIL HYDROCHLORIDE (2000008540)
SUFENTANIL CITRATE (2000006818)
BUPRENORPHINE HYDROCHLORIDE (2000008277)
HYDROMORPHONE HYDROCHLORIDE (2000007868)
5-OXO-5-[PHENYL[1-(2-PHENYLETHYL)-4-PIPERIDINYL] AMINO] PENTANOIC ACID (1000022901)
MORPHINE (1000010779)
CODEINE (1000003912)
COCAINE HYDROCHLORIDE (2000007943)
APOMORPHINE HYDROCHLORIDE (2000008051)
BUPRENORPHINE (1000007171)
DIAMORPHINE (1000003221)
FENTANYL CITRATE (2000007584)
REMIFENTANIL HYDROCHLORIDE (2000007435)
NALOXONE HYDROCHLORIDE (2000008238)
MORPHINE TARTRATE (2000008245)
METHYLPHENIDATE HYDROCHLORIDE (2000008305)
COCAINE (1000003943)
OXYCODONE (1000007438)
CODEINE PHOSPHATE HEMIHYDRATE (4000006570)
MORPHINE SULFATE (4000006163)

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