Wockhardt's Chikalthana unit gets US FDA import alert

In May, US health regulator had also issued an import alert on the company's Waluj facility

In another setback to troubled pharma company Wockhardt, the US Food and Drug Administration (FDA) has imposed an import alert on its manufacturing unit at Chikalthana, Aurangabad, in Maharashtra. The plant had generated sales of $283 million (Rs 1,700 crore) in financial year 2013.

However, FDA has excluded five products from import alert. “The company has already initiated several steps to address the observations made by FDA and shall put all efforts to resolve the matter at the earliest,” said a statement from Wockhardt.

Following the import alert, shares of Wockhardt plunged 14 per cent in early trade on the BSE exchange to Rs 406 a share. They closed the day at Rs 430.15, down 8.87 per cent.  

REGULATOR ALERT

• May 2013: US Food and Drug Administration import alert on Waluj Plant
• July 2013: UK Medicines and Healthcare Products Regulatory Agency import alert on Waluj plant
• Oct 2013: UK MHRA withdraws Good Manufacturing Practice certificate for Daman plant
• Oct 2013: UK MHRA withdraws GMP for Chikalthana plant
• Nov 2013: US FDA import alert on Chikalthana plant

At the Chikalthana plant, Wockhardt makes the generic version of Toporol XL, a cardiac drug. The company has 26 per cent of the market share in the US for the drug. The plant’s annual revenue from the UK and Europe is £12 million (about Rs 120 crore).

An import alert results in detention without physical examination of drugs from firms that do not meet the good manufacturing practices (GMP), according to FDA. Sarabjit Kaur Nagra of Angel Broking said the alert will have a long-term impact as it could take one to two years to rectify the issues.

“Shifting productions to new plants will also take a minimum period of one year with final approvals as well as product-wise approvals,” she said. In October, UK medical regulator, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had also withdrawn the GMP certification for the Chikalthana factory, where FDA had earlier reported quality concerns. In May, FDA had imposed a ban on the company’s Waluj plant after inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area.

According to a statement issued by the company earlier, the US regulator had inspected the Chikalthana plant, hit by the latest regulatory action, in July and had made some observations about the manufacturing practices.

In order to start its export to the US in a full fledged manner, the company has been trying to shift the production to its Shendra unit in Aurangabad. Wockhardt said inspection there by MHRA had been done and there were no critical or major observations.