The US regulator has slammed India’s Emcure Pharmaceuticals in a warning letter, accusing the company of slipshod investigation of tests showing microbial contamination and poor supervision, and has also sent a Form 483 containing eight observations to Dr Reddy’s.

Heritage has clarified that its recent settlement deal with the US Department of Justice over price-fixing allegations did not include the company entering a guilty plea.

For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.