Ranbaxy Laboratories announced in April 2012 that the FDA had approved its plant in Mohali to manufacturer generic Lipitor. It was an indication of sorts that India's largest generic drugmaker was on its way back after years of problems with the FDA. Two other of its Indian plants were barred from shipping to the U.S. for problems that last May it agreed to settle with the U.S. for $500 million. But the recovery was short-lived. The Mohali plant, its last in India approved to make drugs for the U.S., has now also been banned from shipping to the world's largest market.
The FDA said in an announcement Monday that it had placed the Mohali plant on import alert after inspections in September and December of last year found significant cGMP violations. The agency said the plant will now have to conform to provisions of a consent decree that Ranbaxy agreed to last year, which initially was written to cover its Paonta Sahib and Dewas facilities. Those two plants have been banned from exporting to the U.S. since 2008.
It is a huge blow to Ranbaxy, which makes generic Lipitor at the Mohali plant. It is believed by analysts to be the plant that was to make generic Diovan, another potentially big seller for Ranbaxy. Diovan is Novartis' ($NVS) top-selling hypertension remedy and lost patent protection in September 2012, but Ranbaxy's exclusive generic has yet to be approved by the FDA. With the three Indian plants under import alert, the company has only a plant in New Jersey to supply drugs to the U.S., a market Reuters says accounts for more than 40% of its sales. The company said Tuesday that it would work to resolve the issues.
But the announcement later Monday said the plant would be kept from manufacturing drugs for the U.S. until its cGMP problems were resolved. It said the company would be required to hire a third-party expert to inspect and certify the plant before it would be approved. The agency, however, said it did not expect a "supply disruption or shortage of drugs" in the U.S. as a result of its action against Ranbaxy.
By being included in the consent decree that already exists between Ranbaxy and the FDA, the plant may become subject to a long list of requirements. The decree ordered the company to hire experts in data integrity and manufacturing to watch over its shoulder, make recommendations, and, if they don't like the responses they get, take the issues up with the FDA. It also required Ranbaxy to set up a whistleblower program. All of these stipulations were set in place after the FDA learned that Ranbaxy was not meeting FDA quality standards at the plants but was faking data to hide that fact. In May, the company finally settled with U.S. authorities over the problems, agreeing to the record-setting payment and pleading guilty to three felony counts.
There have been indications that Ranbaxy was experiencing issues at the Mohali plant. Last year, glass particles were found in the active pharmaceutical ingredient (API) it needed for generic Lipitor. The company had to recall 41 lots, a move that wiped out its U.S. market share for the generic. There also have been ongoing delays in getting generic Diovan to market, a drug that went off patent a year ago. And in June, there were reports in Indian media that the plant had been issued a Form 483 by FDA inspectors for problems there.