HYDERABAD: GVK Biosciences Pvt Ltd has come under the scanner of the European Medicines Agency (EMA) for alleged violation of manufacturing norms.
It may be noted that recently, French medicines agency ANSM had initiated an inspection raising concerns over the study data used by GVK Biosciences to support the marketing authorisation applications of generic medicines.
According to EMA, it has started a review in connection with findings of alleged non-compliance with good clinical practices at a facility owned by GVK Biosciences, a contract research organisation.
“The review will cover nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences Pvt Ltd, Hyderabad...The review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission”, it said.