Bioequivalence Studies

Jump to

EU regulator recommends suspending 300 drugs tested by Indian CRO firm

The European Medicines Agency (EMA) said that the suspension has been ordered for all drugs for which the bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.
Will submit clarification to EMA on clinical study data:Alkem

Drug maker Alkem Laboratories today said it will submit 'suitable clarifications' to the European Medicines Agency (EMA) over a decision by the drug regulator to review two drugs for which clinical trial studies were conducted by the Mumbai-based firm.

Advisory Alert: It has come to our attention that certain individuals are representing themselves as affiliates of Moneycontrol and soliciting funds on the false promise of assured returns on their investments. We wish to reiterate that Moneycontrol does not solicit funds from investors and neither does it promise any assured returns. In case you are approached by anyone making such claims, please write to us at grievanceofficer@nw18.com or call on 02268882347

Bioequivalence Studies

EU regulator recommends suspending 300 drugs tested by Indian CRO firm

Will submit clarification to EMA on clinical study data:Alkem