Regulatory history

EUROPE


CELRÀ SITE, SPAIN


- FDA (US Authorities) February 2019


- GENERALITAT DE CATALUNYA (National Authorities) June 2018


- KFDA (MFDS) (Korean Authorities) April 2015


- PMDA (Japanese Authorities) April 2007 on-site


Several PMDA GMP documentary inspections related to DMF and products regularly marketed in Japan have also been conducted.

BANYERES DEL PENEDÈS SITE, SPAIN


- AEMPS (National Authorities) March 2019


- FDA (US Authorities) June 2017


- KFDA (MFDS) (Korean Authorities) December 2011


Regulatory history - EUROPE
Regulatory history - ASIA

ASIA


SHAOXING MANUFACTURING SITE, CHINA


- MHRA (UK Authorities) July 2019


- NMPA (National Authorities) March 2019


- FDA (US Authorities) January 2019


- PMDA (Japanese Authorities) May 2018


- KFDA (MFDS) (Korean Authorities) June 2017


- AEMPS (Spanish Authorities) May 2011

AMERICA


JIUTEPEC MANUFACTURING SITE, MEXICO


- COFEPRIS (National Authorities) June 2018


- FDA (US Authorities) July 2017


- PMDA (Japanese Authorities) May 2013


- AEMPS (Spanish Authorities) September 2010

Regulatory history - AMERICA