Panexcell EU Marketing Authorizations At Risk Over Unreliable Data
EMA’s CHMP Recommends Suspending Several Generics From European Market
The EMA’s CHMP has recommended suspending all marketing authorizations for generics tested by Panexcell Clinical Laboratories at its site in Mumbai over inadequate data. To lift the suspension, companies relying on data from Panexcell must provide alternative data demonstrating bioequivalence.