Tag Archives: preapproval

FDA faults Biocon small molecule API facility during preapproval review

The FDA has found a handful of issues with Biocon’s small molecule API facility in Bengaluru, India. The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week of its small molecule API facility. It didn’t say what product it is hoping to get… Read More »