![ANDA](https://www.medichem.es/wp-content/uploads/2020/07/regulatory-affairs-and-quality.jpg)
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](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial.png)
Spanish Medicines Agency
(AEMPS) since 2008
![Catalunya](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial1.png)
Catalunya GMP plant inspection since 2014
R&D hubs in Barcelona and Celrà (Spain) since 2018
![ISO 14001](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial9.png)
ISO 14001 certified
since 2001
![FDA](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial3.png)
FDA inspected since 1985.
No form 483 since 1999
![Korean FDA](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial4.png)
Korean FDA
(MFDS) since 2012
![PMDA](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial5.png)
PMDA approved plants
since 2009
![Halal](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial6.png)
Halal Inspection
since 2016
API+FDF Hal Far Malta
![US FDA](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial7.png)
US FDA inspected since 2007
(API), since 2017 (FDF)
No form 483 since 2012 (API)
![Malta Medicines Authority](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial8.png)
EU GMP certification by Malta
Medicines Authority since 2007
(API) since 2006 (FDF)
![ISO 14001](https://www.medichem.es/wp-content/uploads/2020/07/Objeto-inteligente-vectorial9.png)