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The recent regulatory observations made by the US Food and Drug Administration on its Shendra plant are “non critical”, Wockhardt Chairman Habil Khorakiwala said on Monday, without giving details on the nature of these observations.
He was clarifying on the nine observations made recently by the US FDA on Wockhardt’s Shendra plant, a new facility that was yet to begin its supply to the US.
By the time Wockhardt responds to the FDA’s observations in 15 days, the company would have “cleared and complied” with half the regulator’s observations, Khorakiwala said, adding that the rest would be done in another two months.
Shendra is key to Wockhardt’s US plans, as the company’s plants in Waluj (near Aurangabad) and Chikalthana (also in Maharashtra) already face import bans in the US.
A 483 observation by the regulator is tricky for a company. The storm could blow over, if the company is able to set right the problems pointed out by the regulator.
Otherwise, it could flare-up into a larger problem that could attract warning letters and possible import bans.
Wockhardt shares that had plunged on the news, recovered on the clarification from the management. The stock closed six per cent lower at ₹1,208 on the BSE.
The management sees the Shendra development as “positive”, Khorakiwala said, in that the inspection was due for about six months and the company now had the opportunity to move forward.
The Shendra facility is large and equipped to make liquids, ointments, tablets, capsules and injectables and all dosage forms, Khorakiwala said, adding that it supplied to the United Kingdom and Ireland.
He added that all Wockhardt’s plants were in compliance with the UK regulator.
About 14-15 filings for products have been made from Shendra, he said, adding that a couple-odd products that were earlier made at Waluj and Chikalthana had also been shifted to Shendra.
The company’s product filings for the US now include a third-party, he said, adding that about 15 filings had been made.
The drugmaker was in dialogue with the US regulator to sort out earlier 483 observations made on its other plants, he said, adding that he expected some issues to get resolved in the coming months.
The FDA observation on one more of Wockhardt’s plants comes even as other drug majors deal with similar regulatory action in the US.
From Sun Pharma and Ranbaxy (now in the Sun fold), to Zydus Cadila and Dr Reddy’s Laboratories, to name a few – companies are in the remediation process with plants that export to the US.
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