Federal prosecutors believe that Indian generic drug maker Ranbaxy Laboratories deliberately misled the U.S. government about the quality of its low-cost medicines. The Justice Department is demanding that Ranbaxy turn over documents that it hopes will prove the company fabricated data to convince the government to approve its products. Ranbaxy is India’s largest pharmaceutical company and claims to be the tenth largest generic drug maker in the world. The government has been investigating Ranbaxy since 2006, when the Food and Drug Administration issued a warning letter over manufacturing violations found at a company plant in India.
Last year, government officials seized paper and electronic documents from Ranbaxy’s U.S. headquarters in New Jersey. In the filing earlier this month, Prosecutors say “reliable sources and supporting documents” show the company systematically lied about the makeup of its generic drugs, which include a cheaper version of Zocor, Merck’s blockbuster cholesterol drug. The FDA approves generic drugs based on evidence that they are equivalent to the original medication. The government alleges Ranbaxy’s equivalence data contained “false and fabricated information.” Additionally, the government alleges Ranbaxy uses unapproved ingredients and diluted amounts of ingredients in its drugs.
Source: Associated Press
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