…submitted to date to Regulatory Agencies around the globe
API Celrà ES
Spanish Medicines Agency (AEMPS) since 2008
Catalunya GMP plant inspection since 2014 R&D hubs in Barcelona and Celrà (Spain) since 2018
ISO 14001 certified since 2001
FDA inspected since 1985. No form 483 since 1999
Korean FDA (MFDS) since 2012
PMDA approved plants since 2009
Halal Inspection since 2016
API+FDF Hal Far Malta
US FDA inspected since 2007 (API), since 2017 (FDF) No form 483 since 2012 (API)
EU GMP certification by Malta Medicines Authority since 2007 (API) since 2006 (FDF)
ISO 14001 certified since 2009 (API)
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