Ranbaxy: Looking Under the Rock

Here's an excellent, detailed look from Fortune at how things went off the rails at Ranbaxy and their generic atorvastatin (Lipitor). The company has been hit by a huge fine, and no wonder. This will give you the idea: On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company. (No current or former Ranbaxy executives were charged with crimes.) Thakur's confidential whistleblower complaint, which he filed in 2007 and which describes how the company fabricated and falsified data to win FDA approvals, was also unsealed. Under federal whistleblower law, Thakur will receive more than $48 million as part of the resolution of the case. . . . . .(he says that) they stumbled onto Ranbaxy's open secret: The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. "This was not something that was concealed," Thakur says. It was "common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people. Lying to regulators and backdating and forgery were commonplace, he says. The company even forged its own standard o...
Source: In the Pipeline - Category: Chemists Tags: The Dark Side Source Type: blogs