The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

Ranbaxy to Pay $2.3 Million in Oregon for Poor GMP Compliance

July 11, 2014

Indian generics maker Ranbaxy will pay $2.3 million for selling drugs in Oregon that were manufactured in violation of current good manufacturing practices.

Ranbaxy and two U.S. subsidiaries reached a settlement this month to fully repay the price paid by five Oregon agencies that purchased the generic drugs, along with fines, according to a statement from Oregon’s Department of Justice. Among other violations, the state DOJ accused Ranbaxy of falsifying testing data used in batch records.

The Oregon settlement follows a $500 million settlement last year between Ranbaxy and state and federal authorities over the same issues: poor data integrity and manufacturing practices at three Ranbaxy facilities in India and one in upstate New York. That settlement was the largest of its kind between the U.S. DOJ and a generic manufacturer.

Oregon’s DOJ first threatened to sue Ranbaxy in April, but instead of fighting the case in court, Ranbaxy chose to settle. The agreement between the parties for the $2.3 million payout was accepted by an Oregon circuit court judge.

In the settlement, Ranbaxy continued to deny all allegations of wrongdoing, saying that it agreed only to resolve the matter.  

No one is known to have been harmed by the sale of the cGMP-violating generics, Oregon Attorney General Ellen Rosenblum said.  Ranbaxy said that it was pleased to have resolved the matter.

As it works to clear up a series of manufacturing quality problems, the generics maker’s five Indian plants remain under an FDA import ban. However, the company can still sell drugs in the U.S. made at its American plants. Meanwhile, the European Medicines Agency recently reinstated the GMP certification for one of Ranbaxy’s Indian factories.

Don’t subject yourself to fines by violating good manufacturing practices, make sure your employees are well trained using GMP Training for Drugmakers.