All Raw materials sold by Fagron meet the quality requirements of the TGA, The Pharmacy Board Guidelines and all State Pharmacy Councils.
All Pharmaceutical raw materials are procured from manufacturers audited by the Fagron Global Quality team to ensure they hold a GMP manufacturing license (or other appropriate certification) equivalent to those issued by the TGA, from a regulatory authority which is acceptable to the TGA.
Repackaging activities at Fagron are undertaken at our GMP compliant facilities in the USA, Europe & South America. All facilities hold relevant certifications from international GMP authorities which are equivalent to the TGA. These include the US Food and Drug Administration (USFDA), European Directorate for Quality Medicines (EDQM) & Brazilian Health Regulatory Agency (ANVISA).
Prior to release for sale by a Qualified Person, all raw materials undergo testing by an appropriately accredited, independent laboratory to confirm identity, purity and conformity of raw materials against pharmacopoeia standards (e.g. USP, BP or PhEur).
All Certificates of Analysis (CoAs) are available to customers via our website www.fagron.com.au. If required original manufacturer documentation is also available to Fagron customers upon request through our QIS Global Quality System. This results in full traceability and ensures high quality of all our raw materials.
Please see the attached information providing further details to our unique and unparalleled global quality systems.