Ranbaxy‘s generic pharmaceuticals business in the U.S. has been suspended until it can correct violations at its factories in India and the United States that triggered a federal injunction.
Under the terms of a settlement reached with the U.S. Department of Justice, which described its investigation of the company as “groundbreaking,” the company is to bring its facilities in India and the United States in line with good industry practices. The federal injunction was filed against one of the largest pharmaceutical companies in India and its U.S. operations, headquarters in Princeton, New Jersey.
Its three facilities in India have been under an U.S. Food and Drug Administration import alert since 2008.
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Among the violations highlighted in the case, Ranbaxy did not adequately separate the production of penicillin and nonpenicillin drugs, and failed to take the proper steps to prevent contamination of sterile medicines, according to a Bloomberg report. One condition of the settlement is that the company agrees to relinquish 180-day marketing exclusivity on any drugs pending FDA approval. Three drugs are referred to in the document cited by Bloomberg, but are not disclosed.
As part of the condition for lifting the injunction, the company is required to hire a third-party expert to carry out an internal review at the facilities and audit applications containing data from the affected facilities.
Ranbaxy also needs to establish procedures and controls to ensure data integrity in the company’s drug applications; and withdraw applications with false statements and data irregularities that could affect approval of the application, the statement from the Department of Justice said.
Although the FDA has suspended exports of 30 drugs produced by Ranbaxy, the action does not appear to affect the company’s generic version of Lipitor, approved by the FDA last year. It has an agreement with Teva Pharmaceuticals’ U.S. arm for a portion of the profits from sales during Ranbaxy’s 180-day, first-to-file exclusivity period.
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