This story first appeared in DNA Money edition on Saturday, May 25, 2013.
Drugmaker Wockhardt has stepped up efforts to mitigate the impact of an ‘import alert’ by the US Food and Drug Administration (FDA) for its units at Waluj in Aurangabad. The company will hire a US consultant and submit a corrective action plan within a fortnight.
”The consultant will be helping us in bringing this facility in compliance in a month or two maximum,” said Habil Khorakiwala, chairman, Wockhardt, during an analyst call on Friday.
Wockhardt has two facilities at Waluj, — one manufacturing injectables for the US and another that is not for US exports but has a product filed in that area.
”The FDA has observed non-compliance in terms of standard operating procedure and several other areas. This we are in the process of correcting. We will have clear replies to FDA within 15 days of the corrective measures and timelines we propose in terms of correction,” said Khorakiwala.
As a result of the import alert, Khorakiwala expects Wockhardt’s revenues to be impacted by Rs 550 crore, while margins are likely to be down 2%.
Anshuman Gupta & Prashant Nair, analysts with Citigroup, on Friday said they see revenues hit on two counts viz. discontinuation of approved products like Geodon, Comtan, Stalevo, Zithromax etc and delay in new approvals from the unit.
”While we don’t know how many abbreviated new drug applications (Andas) were filed from Waluj, we believe the list includes a few key products such as Reclast, Zometa, Adenoscan, Tricor, Arthrotec over this and next fiscal. We cut our topline estimates for the 2 years by $140m/$180m and await more clarity on potential mitigating measures (site transfers for instance) Wockhardt can explore,” Gupta and Nair said in a note.
Khorakiwala said Wochardt has over 47 Andas pending of which 50% has been filed from the facility that has received an import alert.
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