The battle continues on but once the FDA opens offices in India, perhaps that will help out being close to the source to ensure safety and compliance. Meanwhile Ranbaxy is business as usual with continuing to submit new drugs and information to the FDA, and they are the 15th largest producer of drugs in the world, however the US and Europe account for over 60% of the business, so a tainted name is not good.
Now it appears Congress is a bit confused too over the investigation, why were the products still left on the market if there was a problem, good question anyone would want to know I think. More growing pains for the FDA. BD
For now, Ranbaxy continues to receive new approvals from the FDA for other drugs. For instance, it has negotiated 180-day exclusivity in the U.S. for generic versions of drugs that have a market size of more than $32 billion, including AstraZeneca's (AZN) Nexium. Singh says the company is making plans for what to do with its $800 million war chest and debt-free balance sheet, hinting at acquisitions both locally and internationally. "I clearly see the industry continuing to consolidate," he says. "We are just waiting for the transaction to close.&We expect to do something in the next year.
"Unfortunately," wrote the two members of the House Energy & Commerce Committee, "the FDA's alleged lack of action to remove these suspected products from the market requires this committee to review the pre-market approval inspections of all currently marketed Ranbaxy drugs, as well as any 'for cause' inspections, to determine if [the] FDA has expended the resources required to justify leaving these suspect drugs on the market."
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