Carcinogens in drug: US FDA seeks full re-evaluation in all Aurobindo units

Firm may have a tough task ahead improving manufacturing practices across the board through remediation running into months and years

The generalisations drawn and operation-level observations made by the US Food and Drug Administration (US FDA) in its warning letter to Aurobindo Pharma, over the deviations at the company's active ingredient(API) Unit XI in Srikakulam district, go much beyond the problem of valsartan impurities. They are, in fact, contrary to what the company management believed till it got the letter dated June 20 recently.

Most of the corrective action prescribed by the US drug regulator requires a complete re-evaluation of Aurobindo's manufacturing operations, and is not just limited to the unit currently under radar. As a result, Aurobindo may have