Wockhardt unit receives US FDA flak

Pharma company exports products from the Shendra plant to Ireland and Britain

Drug maker Wockhardt’s plans to revive its business in the United States has suffered a setback, with the  US Food and Drugs Administration (FDA) raising concerns about manufacturing practices at the company’s Shendra plant in Maharashtra.

The drug maker, led by chairman Habil Khorakiwala, plans to use the facility at Shendra to export oral solids and injectables to the US, as its facilities at Chikhalthana and Waluj have import alerts against them.

The company had sought approval from the US FDA for its Shendra plant in order to commence exports to the US and an inspection was carried out last week. The FDA issued adverse observations, known as Form 483, following its inspection.

The company’s stock fell nearly 15 per cent following the reports and closed at Rs 1,288.4 on the BSE on Friday. The stock was also affected by the recall of 62,555 bottles of Wockhardt-manufactured antibiotic tablets by PD-Rx Pharmaceuticals in the US. On NSE, the stock closed at Rs 1,287, down 15.04 per cent from the previous close.

“The FDA has made nine observations. These are not critical observations and we will reply within fifteen days,” a Wockhardt executive said.

“Shendra manufacturing unit is a new facility and presently there are no supplies of products from the said unit to the US markets,” the company said in a notification to the stock exchange.

At present, the company exports to Ireland and Britain from Shendra plant. “We have already received full clearance from United Kingdom Medicines and Healthcare Products Regulatory Agency for the Chikhalthana plant,” the executive added.

Also, the company is awaiting clearance from US FDA for Chikhalthana and Waluj plants. Inspections at both these plants were carried out in May. At present, the company is able to export only two products from Chikhalthana to the US. Other than this, Wockhardt serves the US market from its manufacturing plant in Chicago.

The share of US market as a part of total has slipped to 24 per cent from about 45 per cent two years ago, while the Britain and Indian markets are showing growth. In the last financial year, revenue form the US market dropped 50 per cent to Rs 1,087 crore.

“Prospects of US business revival will be hampered following the observations on Shendra plant,” an analyst remarked.

TURN OF EVENTS

• April 2015: Wockhardt recalls products from US after FDA inspection. Regulator makes observations regarding products made prior to the alert
   
• May: US FDA completes inspection at Waluj. Firm still to receive clearance for the plant
   
• July: US FDA carries out inspection at Baddi. No adverse observations  in the inspection
   
• Dec: UK health regulator grants full clearance to Chikhalthana plant
   
• Jan 2016: FDA issues adverse observations following inspection at Shendra plant