Following their successful scale-up and validation of US-based Cephalon's modafinil manufacturing processes, Helsinn Chemicals and Helsinn Advanced Synthesis - both of Biasca, Switzerland - have received Cephalon's "Partners in Growth Award" for excellence.
Modafinil is the active pharmaceutical ingredient in Provigil - Cephalon's largest commercial product - and two new pharmaceutical products pending regulatory approval: Sparlon and Nuvigil.
Helsinn worked with technical team members from Orsymonde, Cephalon's French subsidiary, to execute and implement the technology transfer, scale-up, process validation and quality review within "an aggressive timeline".
Furthermore, the company's technology transfer and regulatory team prepared and submitted information for the drug master file to accompany Cephalon's supplemental new drug application, which went on to gain approval from the US FDA within four months.
Vincent Djuhadi, Cephalon's associate director of global process development, presented the award to Dr Gabriel Haering, director of business development at Helsinn Chemical Operations.