CONSENT DECREE RANBAXY PDF

Federal government websites often end in. The site is secure. The United States has filed a consent decree for permanent injunction against the generic drug manufacturer Ranbaxy Laboratories Ltd. These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date. The government also determined that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed.

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The consent decree requires Ranbaxy to conduct an internal review of all negligent facilities using a third-party expert audit applications containing data from the facilities in question, take steps to ensure data integrity going forward and withdraw any pending applications that use irregular data.

FDA has prevented drug products manufactured from the sites from entering in to the country since , when it issued an import alert after learning of the issues. The company has agreed to "relinquish any day marketing exclusivity that it might have for three pending generic drug applications," FDA said in a statement. Reuters reported that the names of those three products were filed under seal and were not available to the public. Ranbaxy made waves several months ago when it revealed that it had received day exclusivity rights to the generic version of Lipitor.

It is unclear if this exclusivity is threatened by the agreement. Additional manufacturing facilities may also be placed under the consent decree if further problems are found with those plants. The consent decree's mandatory activities could mean a month delay in abbreviated new drug approvals, said analysts that spoke to BBC News. The consent decree is subject to court approval, at which time it will immediately go in to effect.

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