US federal officials have conducted a "surprise" search of Ranbaxy Laboratories' US corporate offices in Princeton, New Jersey, but the Indian drug major does not know why.
In a statement issued on Thursday, Ranbaxy said the search on Wednesday came "as a surprise", and the company was not aware of any wrongdoing.
The US Federal Drug Authority (FDA) said it could not "confirm or deny FDA involvement" in the Ranbaxy case, while the federal prosecutor's office in Maryland — where the FDA is headquartered — said it could not comment on pending investigations.
A spokesman for the Ranbaxy US affiliate said officials of the US Food and Drug Administration conducted a broad search of the premises "and took a variety of documents".
"It's been a wide dragnet-a sweep of questions-and we've tried to work with them in answering everything they've asked," Charles Caprariello said. "But there are a lot more questions than answers right now."
The search of Ranbaxy's US offices came within a week of the Indian company receiving FDA's final approval to manufacture and market in the US its formulation for the treatment of major depressive disorders in adults. FDA approved Ranbaxy formulation of Sertraline Hydrochloride was determined to be bioequivalent and have the same therapeutic effect as that of Pfizer Pharmaceuticals' Zoloft(r). The drug has an estimated annual market sale of $3.07 billion.
Ranbaxy, which entered the US market in 1995, makes generic versions of many other such drugs and sells it at a fraction of the price of patented drugs.
"Ranbaxy, today, operates in a complex global business environment in one of the most highly competitive and regulated industries. Over the decades, the company has consistently delivered high quality affordable medicines to millions across the world — including those in the most demanding markets," the company said in a statement confirming the search.
According to the company website, "The mainstay of Ranbaxy's business in USA is the contribution made by its generic pharmaceutical business, first launched in January 1998, and now possessing a product basket comprising 96 products approved by the US FDA."
Ranbaxy sales in the United States, where the company introduced 10 new products last year, are currently around $ 350 million. It is aiming for $ 5 billion US sales by 2012.