Pharmatory is committed to operating in accordance with current Good Manufacturing Practise (cGMP) as defined by the current EU, ICH and FDA Guidelines to Active Pharmaceutical Ingredients.
Pharmatory has been routinely inspected since 2001 by the Finnish Medicines Agency making us a reliable Europe-wide supplier of APIs. Inspections are also frequently carried out by our customers.
From an early developmental stage
cGMP projects at Pharmatory generally begin at an early developmental stage and the produced materials are used for preclinical and/or clinical testing. Pharmatory manufactures both intermediates and final APIs; orphan drugs and APIs used for veterinary drugs are important part of our GMP manufacture.
The batch documentation (equivalent to CMC documentation) and cGMP QA/QC management are standard procedure for us; if necessary, we can help to determine the cGMP requirements together with the customer, based on each stage of the API development.