We offer our clients high quality formulation development services for the regulated markets in the US and the European Union (region). The facility houses a state-of-the art formulation development laboratory, an analytical laboratory and a cGMP certified pilot plant.
Batches can be manufactured for clinical studies, pilot and pivotal bio-studies as well as for process validation
Batch sizes can range up to 100 kg
GMP
This factory is approved by Netherlands FDA hence qualify as an EU approved GMP set up for the manufacture of solid dosage form drugs, conducting stability studies, followed by the compilation of dossiers.