NeoOpioid Consortium: PDCO gives its approval to PIP for Fentanyl-citrate

The NeoOpioid Consortium within the FP7 initiative has successfully passed the stage of approval for its PIP.  The application to the PDCO at the EMA was coordinated by EPMC Pharma.

Anne Soetemont, Director, Research and Development, EPMC Pharma, comments:

“There is a great deal of enthusiasm among the medical team in this consortium to deliver a suitable product to the market.  EPMC and its consortium partners are helping to structure the necessary steps in the procedure so that we can make a safe new formulation of a well known medicine more readily available to NICUs as soon as possible, by efficiently sourcing partners and navigating the approvals process.”

“We now enter into the phase of identifying a suitable sourcing partner, who can respond to the stringent quality norms for such a product and provide flexible order quantities. We will then manage the new formulation through clinical studies and its registration process, as we would other new medicines on behalf of our clients.”

“EPMC is committed to bringing the best adapted treatments to the European market for neonatal children, whether as part of a consortium, under our own commercial initiative or with other pharmaceutical or biotech companies.”