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FDA extends Ranbaxy ban

pharmafile | January 27, 2014 | News story | Manufacturing and Production, Sales and Marketing API, FDA, Ranbaxy, toansa 

India-based generic manufacturer Ranbaxy Laboratories has been dealt a further blow as the US regulator has banned more of its products destined for US consumers.

The US Food and Drug Administration has prohibited Ranbaxy from manufacturing and distributing active pharmaceutical ingredients (APIs) from Toansa, Punjab, for FDA-regulated drug products.

Toansa makes around three-quarters of all the actives used in its generic products, and the company’s reduced ability to supply the US market – which accounts for around 40% of its turnover – has already had a material impact on its finances.

Ranbaxy, which is majority-owned by Japan’s Daiichi Sankyo Co, ‘voluntarily and proactively’ suspended shipments of API from Toansa to the US when it received the FDA’s Form 483 earlier this month, following an inspection.

But the new ban also covers drugs made by Ranbaxy’s Ohm Laboratories in New Jersey – a real problem for Ranbaxy since the green light shown to that facility by the FDA was something of a lifeline, opening a conduit to supply drugs to the US market.

Access to the US market is particularly important because Ranbaxy has marketing exclusivity for the first generic version of Novartis’ big-selling high blood pressure drug Diovan (valsartan) – but Ranbaxy has been unable to capitalise.

And now Ranbaxy cannot export any APIs from Toansa to the US for any purpose – and cannot provide material from there to other companies making products for the US market, the FDA insists.

Ranbaxy said it is “disappointed with the recent FDA action” and apologised “for the inconvenience caused by the suspension of shipment”.

“This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation,” said Arun Sawhney, Ranbaxy’s chief executive.

In a statement, Ranbaxy reiterated that it was committed to patient safety and quality, and said it would strengthen its systems and processes.

It also pledged to “cooperate with the FDA and…comply with the consent decree in both letter and spirit”.

However, the company’s manufacturing problems have rumbled on over the last couple of years, with six Ranbaxy facilities now found to have problems meeting current good manufacturing practice standards – and at four of these the issues have been serious enough for the FDA to take direct enforcement action.

The FDA consent decree also encompasses the Ranbaxy facilities in Paonta Sahib, Dewas and Mohali.

Last May the company was forced by the US government to pay $500 million in fines and penalties to settle criminal and civil charges related to charges of selling adulterated drugs.

Sawhney is aware the firm may be skating on thin ice. In an open letter to stakeholders on the company’s website, he said: “We would like to thank you for your firm support. We remain committed to our stated values and to upholding the highest quality standards that patients, prescribers and all other stakeholders expect from Ranbaxy.”

Adam Hill

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