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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 29350
2. Name or corporate name of registrantSTERLING PHARMA SOLUTIONS LIMITED
3. Permanent or legal address of registrant STERLING PHARMA SOLUTIONS LIMITED, DUDLEY LANE, DUDLEY, CRAMLINGTON, NE23 7QG, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

STERLING PHARMA SOLUTIONS LIMITED, DUDLEY LANE, DUDLEY, CRAMLINGTON, NE23 7QG, 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 24/11/2023

 

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

STERLING PHARMA SOLUTIONS LIMITED, DUDLEY LANE, DUDLEY, CRAMLINGTON, NE23 7QG, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
CANNABIDIOL
1000000540
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
DIMETHYL FUMARATE
1000000359
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
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
F.2 Microbiological testing (excluding sterility testing)
Active substance
TRIENTINE DIHYDROCHLORIDE
2000008583
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
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
POLIDOCANOL
4000009871
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
E General Finishing Steps
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
SELAMECTIN
1000021010
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
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
OCTENIDINE DIHYDROCHLORIDE
4000009067
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
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
CERIUM NITRATE
4000008591
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
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
RACTOPAMINE HYDROCHLORIDE
2000019613
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)
Purified via filtration
E General Finishing Steps
E.1 Physical Processing Steps
Filtration
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
LEVALBUTEROL TARTRATE
4000014956
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
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
ILOPERIDONE
1000000868
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, (Micronisation)
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.3 Salt Formation / Purification Steps (e.g. Crystallisation)
Crystallisation
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
METHOXYFLURANE
1000000247
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
DIROXIMEL FUMARATE
1000020604
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
CODEINE PHOSPHATE
2000007940
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
LEVALBUTEROL HYDROCHLORIDE
4000002312
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
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
TOCERANIB PHOSPHATE
2000019612
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
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
LUMACAFTOR
1000017498
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
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
TAZEMETOSTAT
3000018209
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
FERRIC MALTOL
2000006388
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
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
ZILEUTON
1000003010
A Manufacture of Active Substance by Chemical Synthesis
A.1 Manufacture of Active Substance Intermediates
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
ARFORMOTEROL
1000017736
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
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
SISAPRONIL
1000021013
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
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
ACRIVASTINE
1000009451
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
SESTAMIBI
1000010895
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
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
REBOXETINE METHANESULPHONATE
4000006214
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, Sieving
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing

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