FDA throws Ranbaxy a manufacturing lifeline
pharmafile | October 15, 2013 | News story | Manufacturing and Production | FDA, Ranbaxy, recall
Problems have plagued Ranbaxy’s manufacturing operations in the last couple of years, but it enjoyed a bit of light relief this week after its Ohm Laboratories unit was shown the green light by the FDA.
Ohm’s facility in New Brunswick, New Jersey was the subject of a Form 483 from the US regulator after it failed an inspection last year, but the recent filing of an Establishment Inspection Report (EIM) by the FDA effectively brings the enforcement action to a close.
That is a critical development for Ranbaxy, as the New Brunswick plant is the only solid oral dosage form facility currently approved to supply medicines into the US market.
In September the FDA issued an import alert on Ranbaxy’s Mohali manufacturing facility in the Punjab – the third to come under that form of enforcement action. Ranbaxy had already received a series of warnings from the FDA regarding plants in Dewas and Paonta Sahib in India, which resulted in an import ban being imposed in 2008.
The rehabilitation of Ohm means that Ranbaxy now has a platform to start restoring supplies of its products to the US market, which accounted for 40% of its revenues in 2012. The Indian drugmaker may be able to transfer production of some new generic drug applications from Mohali, although its ability to return to normal operating levels in the US hinges on the remediation of its Indian plants.
The problems at its plants have had a material impact on Ranbaxy’s business, as it was forced to pay $500 million in fines and penalties in May with the US government to settle criminal and civil charges related to charges of selling adulterated drugs.
It has also seen its top-line hit, with revenues down 27% in the first half of this year compared to the same period of 2012. The company was forced to suspend sales of its generic version of Pfizer’s Lipitor (atorvastatin) last year after glass particles were found in some batches of the drug. Ranbaxy had launched atorvastatin in the US market in December 2011, supplying its product from Ohm’s New Brunswick facility as well as Mohali, but called halt to production just under a year later.
During that time it had sold around $600 million-worth of the generic thanks to having first-to-file exclusivity for the first six months of sales, although other generic players had entered the market by the time the suspension was announced. The New Brunswick unit was eventually cleared to start making atorvastatin again in March of this year, although a ban was maintained on supplies from Mohali.
Ohm Labs was also sent a warning letter by the FDA in 2009 after an inspection uncovered Good Manufacturing Practice violations at a liquid manufacturing facility it operates in Gloversville, New York. That plant was deemed unfit for remediation and closed down in 2011.
Phil Taylor
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