USFDA move not to hurt growth, new product nods to be delayed: Aurobindo

Aurobindo Pharma has said the recent US Food and Drug Administration (FDA) action won’t affect growth though there will be delay in some new product approvals.

The company’s stock took a beating after the USFDA pointed out data integrity lapses at the firm’s formulations facility in Telangana’s Bachupally. Earlier, the USFDA had classified three of its facilities as official action indicated (OAI), which means the regulator found objectionable conditions or practices.

“There are opportunities in terms of improvement in volumes of existing products and new launches in both orals and injectables. So, we are confident about growth,” Aurobindo Pharma Managing Director N Govindarajan said in a recent analyst call.

The firm has said the OAI move was specific to hypertension product valsartan, which has been withdrawn by firms across the world owing to nitrosamine impurities detected in the drug last year.

The company also said that there was no way of spreading this contamination.



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