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 31890
2. Name or corporate name of registrantALMAC SCIENCES LIMITED
3. Permanent or legal address of registrant ALMAC SCIENCES LIMITED, ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5QD, UNITED KINGDOM
4. Address(es) of site(s) where registered activities take place

ALMAC SCIENCES LIMITED, ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, NORTHERN IRELAND, BT63 5QD, UNITED KINGDOM

5. National legal basis of registration
6. Name of responsible officer of the competent authority of the member state validating the registration Confidential
7. Date 10/06/2024

 

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

ALMAC SCIENCES LIMITED, ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, NORTHERN IRELAND, BT63 5QD, UNITED KINGDOM

1. MANUFACTURING OPERATIONS

Active substance
ACTIVE SUBSTANCES FOR CLINICAL TRIALS
1000018046
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, distillation, chromatography or similar alternatives
E General Finishing Steps
E.1 Physical Processing Steps
micronisation
E.2 Primary Packaging
E.3 Secondary Packaging
E.4 Other
Blending & Milling
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
SELEXIPAG
3000017276
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
micronisation
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
URIDINE TRIACETATE
2000017443
A Manufacture of Active Substance by Chemical Synthesis
A.2 Manufacture of Crude Active Substance
A.3 Salt Formation / Purification Steps (e.g. Crystallisation)
crystallisation
E General Finishing Steps
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
REZAFUNGIN ACETATE
2000019268
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)
purification step using Prep Chromatography
A.4 Other
Freeze Drying
E General Finishing Steps
E.1 Physical Processing Steps
Blending
E.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
Active substance
AMIFAMPRIDINE PHOSPHATE
2000018682
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.2 Primary Packaging
E.3 Secondary Packaging
F Quality Control Testing
F.1 Physical / Chemical testing
2. IMPORTATION AND DISTRIBUTION OPERATIONS
B Distribution
SELEXIPAG (3000017276)
URIDINE TRIACETATE (2000017443)
REZAFUNGIN ACETATE (2000019268)
AMIFAMPRIDINE PHOSPHATE (2000018682)