Drug-maker Wockhardt’s regulatory woes look set to continue, as fresh observations have been made by the US regulatory Food and Drug Administration on its Chikalthana plant (Aurangabad) and cephalosporin unit at Waluj.
Managing Director Murtaza Khorakiwala said that joint inspections were conducted by regulators from the US and the UK at the Chikalthana plant and cephalosporin unit at Waluj, near Aurangabad. While the observations on the cephalosporin unit were “not critical”, there were “483 observations” made on the Chikalthana plant, he told analysts.
Companies are expected to respond to the 483 regulatory observations within a time-frame, and if the responses do not satisfy the US regulator, it could result in a warning letter.
The inspections were held in late July and Wockhardt would respond by next week, Khorakiwala said, adding that they were working closely with US-based consultants Lachman Consultants towards a comprehensive response. Efforts were on to ensure that these observations would not escalate into a warning letter or import alert, he added. The plant, a key revenue contributor, accounts for revenues of about $230 million, he added.
The company, already facing regulatory action from the US and UK on one of its units at Waluj, has taken remedial steps, he said, including ensuring that quality reporting from its plants is directly to the Managing Director, as opposed to the research department earlier, he added. The total impact of existing regulatory concerns is expected to be seen over the next few quarters, he indicated. The management had earlier indicated that the US FDA warning letter on Waluj would have an annual impact of Rs 550 crore, while there would be a one-time impact from the UK ruling of about Rs 13.5 crore.
Profit down 16%
Meanwhile, Wockhardt’s profit after tax dipped about 16 per cent at Rs 324 crore for the three months ended June 30 compared with Rs 378 crore in the corresponding period last year.
It clocked a consolidated revenue of Rs 1,358 crore for the quarter under review, marginally up from Rs 1,342 crore in the same period last year.