Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 40699 Insp GMP 40699/7634946-0008

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 : APTUIT (OXFORD) LIMITED
 
Site address : APTUIT (OXFORD) LIMITED, 110-111 AND 117 INNOVATION DRIVE, MILTON PARK, MILTON, ABINGDON, OX14 4RZ, 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 06/09/2021, 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:

  • [1000002302] FENFLURAMINE
  • [1000010236] LENALIDOMIDE
  • [1000015396] PLERIXAFOR
  • [2000006383] FROVATRIPTAN SUCCINATE
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
FENFLURAMINE
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)
Chloride salt formation followed by purification by crystallisation.
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Drying
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

LENALIDOMIDE
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)
FINAL STEP INVOLVES CRYSTALLISATION
3.5General Finishing Steps
3.5.1  Physical Processing Steps
MANUFACTURE INVOLVES DRYING, MICRONISATION
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

PLERIXAFOR
3.6Quality Control Testing
3.6.1  Physical / Chemical testing

FROVATRIPTAN SUCCINATE
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)
Salt formation and crystalisation then drying
3.5General Finishing Steps
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

Contact Details
11/10/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential