Shares of pharmaceuticals company IPCA Laboratories Ltd are down by more than 7 per cent following reports that the company had got an alert from US pharma regulator USFDA for its Ratlam unit.
However, the company has come out with a clarification that it had already voluntarily suspended APIs shipments from this plant.
In a communication to the stock exchanges, IPCA Laboratories Ltd drew attention to its letter on July 24, 2014, about the outcome of USFDA inspection at its Active Pharmaceutical Ingredients (APls) manufacturing unit at Ratlam in Madhya Pradesh. During the inspection, IPCA said, it had received some inspection observations in Form FDA 483 from the USFDA following which it had `voluntarily decided to temporarily suspend API shipments’ from this facility to the US markets till this issue was addressed. The company said that the USFDA on January 22 has issued an import alert to the Ratlam manufacturing facility.
IPCA however said that the four APIs produced at Ratlam unit - Hydroxychloroquine Sulfate, Propanolol Hydrochloride, Trimethoprim and Ondansetron were excluded from the alert and reiterated that it was "fully committed in resolving this issue at the earliest".
Sarabjit Kour Nangra (VP Research - Pharma, Angel Broking), Mumbai, commenting on the developments, said that the USFDA had banned imports from Ipca Laboratories Ltd's Ratlam unit "due to violations of standard production practices". Ipca had voluntarily stopped shipments from this plant to the US. She said "we are not changing our estimates as we had already pruned the same when company got a 483’s’ and maintained buy recommendation with a price target of ₹817 for the stock.
Shares of IPCA are down by ₹54.30 or 7.76 per cent to ₹645. The stock had touched a high of ₹681.05 on the BSE before losing ground on reports of USFDA action.
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