Drug major Aurobindo Pharma Ltd said on Monday it expects regulatory action leading to the worldwide recall of its hypertension product valsartan will not impact growth.
The company said it was confident that the contamination in valsartan will not spread to other products.
“From a cleaning validation perspective, they (regulators) have tested all the samples subsequent to the sartan products, which have been made in the same set of equipment in the past, and we have not seen any contamination of these impurities in any other non-sartan products, ” said N Govindarajan, managing director of Aurobindo Pharma, in a recent analyst call.
He said that they were fairly confident about growth even though there will be possible delay in some of the new product approvals owing to these regulatory events.
“There are opportunities in terms of improvement in volumes of existing products and new launches in both orals and injectables. So, we are fairly confident about the growth,” he said.
The company’s stock took a beating after two adverse regulatory events, including the form 483 with 10 observations issued on Bachupally formulations facility occurred in the month of May.
Commenting on the inspection outcome of the formulations facility Aurobindo, in its June 4 filing said none of the observations were repetitive and were more procedural in nature.
Source: Business Standard