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Quality issues and inconsistencies with laser-drilled tablet manufacturing processes at Teva’s Actavis have been flagged up by the FDA following an audit last July at the firm’s plant in Florida, US. The agency noted that similar cGMP observations were found during inspections in 2013, 2016 and 2017.
The FDA is “deeply concerned” after the presence of a third nitrosamine impurity is found in certain generic ARB medicines; Hetero Labs recalls 87 lots of losartan tablets after recent FDA tests show NMBA levels higher than the agency’s interim acceptable intake limits.
Selexis and Turgut have further expanded their biosimilar development partnership by signing commercial license agreements for two undisclosed biosimilar antibodies. Building on previous deals signed in July 2016 and December 2017, the companies are now working together to develop biosimilars to treat oncology and inflammatory diseases.
Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.
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