LONG-STANDING EXPERTISE AT YOUR SERVICE
+1000
MARKETING
AUTHORIZATIONS
425
DMFs
109
ACTIVE ANDAs
WITH OUR APIs
18
CERTIFICATES OF
SUITABILITY
3
FDF ANDAs
SUBMITTED
…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)