Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.
Hikma says its $2.65bn acquisition of Roxane Laboratories will make it the sixth largest firm in the US generics space.