Generic drugmaker Wockhardt hopes to resolve all concerns raised by the US Food and Drug Administration (FDA) over manufacturing practices at two of its plants in the current financial year, its chairman said on Friday.
A resolution of the lapses would allow Wockhardt to resume exports from its two main India plants to the United States, a market that previously accounted for half of the drugmaker's global sales.
Wockhardt has been hit by slowing sales in the United States ever since the FDA banned exports from the company's Waluj and Chikalthana plants in Maharashtra in 2013, citing production quality lapses.
FDA inspected both plants earlier this year to check the actions taken by Wockhardt to address its concerns, Chairman Habil Khorakiwala told reporters, a day after the company reported more than halving of its quarterly net profit.
"We will continue to have a dialogue with them since they have seen all our facilities, and the issues are in front of them," he said. "We have given the whole program of corrective measures."
Wockhardt's sales in the United States dropped 21% to Rs 290 crore ($45.5 million) in the quarter ended March, the company said in a statement on Thursday.
Pressure on the company's profitability and US sales will continue until the ban on its two plants are lifted, Khorakiwala said. Wockhardt is also seeking approval to export to the United States from its Shendra facility in Maharashtra.
($1 = 63.7250 rupees)
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Smart Quarterly
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors


Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share


Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor


Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements


Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
)