Indian pharmaceutical giant Ranbaxy Laboratories Ltd. said Tuesday that it has signed a settlement with the U.S. Food and Drug Administration, committing to bolster its product manufacturing practices.
The company also said it intends to set aside a provision of $500 million to cover any potential criminal and civil liability stemming from an investigation by the U.S. Department of Justice.
Ranbaxy said it has committed to further strengthen its procedures and policies to ensure data integrity and to comply with good manufacturing practices.
The consent decree is subject to approval by the U.S. District Court for the District of Maryland.
The FDA banned the import of more than 30 of Ranbaxy's generic drugs in 2008, citing poor quality at two production facilities in India. The following year, the company received a warning letter from the FDA about manufacturing standards at its facility in Gloversville, N.Y.
In addition, the Department of Justice has alleged that Ranbaxy lied about the ingredients and formulations used in some of its medications.
"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy's history," said Arun Sawhney, Ranbaxy's CEO and managing director.
Earlier this month, Ranbaxy started selling a generic version of Pfizer's drug Caduet, a treatment for high blood pressure and high cholesterol.
Ranbaxy said U.S. sales totaled $339 million over the year ended in September.