Moehs BCN, the new API manufacturing plant, located in Castellbisbal, received the FDA inspection a few days ago.
For five days the inspectors visited the facilities and processes and it was classified as a pre-approval inspection, since this plant had never received the FDA.
Moehs BCN, S.L. It was built in 2013 and has EU-GMP certification since 2014. Our facilities manufacture several APIs and intermediaries for the generic market and as CMO.
Among others, Sitagliptin Phosphate Monohydrate validation batches have been manufactured in this site. Those validation batches are being supplied to our customers for development and registration purposes of the generic versions of the innovator’s drug product in base of Art. 10(6)of Directive 2004/27/EC.
Moehs BCN is fully integrated into the Moehs Group Quality organization.