REGULATORY AFFAIRS AND QUALITY

ANDA

LONG-STANDING EXPERTISE

879
MARKETING
AUTHORIZATIONS
361
DMFs
91
ACTIVE ANDAs
WITH OUR APIs
17
CERTIFICATES OF
SUITABILITY
2
FDF ANDAs
SUBMITTED

…submitted to date to Regulatory Agencies around the globe

API Celrà ES

Spanish Medicines Agency
Spanish Medicines Agency
(AEMPS) since 2008
Catalunya
Catalunya GMP plant inspection since 2014
R&D hubs in Barcelona and Celrà (Spain) since 2018
ISO 14001
ISO 14001 certified
since 2001
FDA
FDA inspected since 1985.
No form 483 since 1999
Korean FDA
Korean FDA
(MFDS) since 2012
PMDA
PMDA approved plants
since 2009
Halal
Halal Inspection
since 2016

API+FDF Hal Far Malta

US FDA
US FDA inspected since 2007
(API), since 2017 (FDF)
No form 483 since 2012 (API)
Malta Medicines Authority
EU GMP certification by Malta
Medicines Authority since 2007
(API) since 2006 (FDF)
ISO 14001
ISO 14001 certified
since 2009 (API)