Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
As Novartis looks to sell a major chunk of its generics portfolio in the US, in-PharmaTechnologist has a look back at some of the stories this year that have signposted larger, on-going trends in the US generics market.
