Inspections & audits

Our facilities are regularly inspected by Health Authorities (European Authorities, FDA, PMDA…) and customers. We have more than 20 years experience with a very good inspections results.

FDA (US) Inspections: 7 FDA Inspections from 1999 to 2023, the last 5 without 483 observations.

PMDA (Japan): 9 Off site inspections. Accreditation certificate of foreign drug manufacturer (2023).

AEMPS / Generalitat de Catalunya (Spain):  3 inspections, last one in May 2018. No major observation. GMP Certificate valid until February 2024.

FDA Inspections

1999 – Approval Dipyridamole

2002 – Approval Mexiletine

2004 – Approval Camptothecine

2009 – Approval Telmisartan

2015 – Routine GMP Inspection

2017 – Routine GMP Inspection

2023 – Routine GMP Inspection

PMDA Inspections (Japan)

2007 – Telmisartan

2010 – Telmisartan

2011 – Telmisartan

2012 – All products

2013 – Epinastine

2013 – Dipyridamole

2014 – Aminoacetate

2015 – Epinastine

2017 – All products

2023 – All products

Local Health Authorities (AEMPS / Generalitat de Catalunya)

2012 – Routine GMP Inspection

2015 – Routine GMP Inspection

2018 – Routine GMP Inspection