- In 2013, after a series of recalls of drugs manufactured by the India-based companies Ranbaxy Labs and Wockhardt, the U.S. enacted a ban preventing those companies from exporting to the America.
- The ban has wreaked financial havoc on Wockhardt, causing the company's net profit last quarter to plummet 97% compared with the same quarter last year.
- Wockhardt has indicated to the FDA that it, as a company, is prepared to have its manufacturing facilities re-inspected. So far, there's been no response from the FDA.
Despite the fact that Wockhardt's stock is up this year in response to buy-out rumors, both Ranbaxy Labs and Wockhardt have had bad, bad years thanks to the ban. The U.S. ordered the halt on exports in response to continuous quality-control issues that led the FDA to question the safety of all products coming from the countries in question.
The ban remains in place, but to their credit, executives at Wockhardt are moving forward with getting their facilities inspection-ready and continuing to file applications with the FDA for new generic drugs—despite the fact that they can't be approved until the FDA lifts the ban.