Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue
Executive Summary
Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.
You may also be interested in...
More Cheer For Biocon-Mylan As Brazil Clears Biosimilar Trastuzumab
Biocon and Mylan have received approval in Brazil for the first biosimilar version of Roche’s Herceptin (trastuzumab). The partners hope to provide an “affordable” option, expanding access to the product in the Latin American nation.
More Cheer For Biocon-Mylan As Brazil Clears Biosimilar Trastuzumab
Biocon and Mylan have received approval in Brazil for the first biosimilar version of Roche’s Herceptin (trastuzumab). The partners hope to provide an “affordable” option, expanding access to the product in the Latin American nation.
US/EU Agreement Will Reduce Global Import Testing Burden
US drug makers will no longer have to retest batches exported to the EU under a mutual recognition agreement provision expected to take effect by July 2019. It's a landmark development in industry's quest to eliminate import testing, which it says wastes time and resources. But many nations around the world still require import testing – our interactive map shows which rules apply where.