Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 31890 Insp GMP 31890/383321-0016

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1
Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : ALMAC SCIENCES LIMITED
 
Site address : ALMAC SCIENCES LIMITED, ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5QD, UNITED KINGDOM
 

Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 16/12/2019, it is considered that it complies with

  • The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.


  • (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
  • (2) These requirements fulfil the GMP recommendations of WHO.
Part 2
Human Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

  • [2000017443] URIDINE TRIACETATE
  • [3000017276] SELEXIPAG
  • [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS
  • [2000018682] AMIFAMPRIDINE PHOSPHATE
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
URIDINE TRIACETATE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation
3.5General Finishing Steps
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

SELEXIPAG
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

ACTIVE SUBSTANCES FOR CLINICAL TRIALS
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

Radiopharmaceuticals
3.1.2  Manufacture Of Crude Active Substance

Radiopharmaceuticals
3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation, distillation, chromatography or similar alternatives
Radiopharmaceuticals
3.5General Finishing Steps
3.5.1  Physical Processing Steps
micronisation
3.5.2  Primary Packaging

Radiopharmaceuticals
3.5.3  Secondary Packaging

Radiopharmaceuticals
3.6Quality Control Testing
3.6.1  Physical / Chemical testing

Radiopharmaceuticals
AMIFAMPRIDINE PHOSPHATE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.2  Manufacture Of Crude Active Substance

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
crystallisation
3.5General Finishing Steps
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

Contact Details
15/10/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential