Ranbaxy drug flows to Europe, US to dry up

Export of medicines made at Ranbaxy's plants in India is expected to gradually dry up with Ranbaxy voluntarily suspending exports from its two plants and Sun Pharmaceutical Industries which acquired Ranbaxy from Japan's Daiichi Sankyo planning a gradual phase-out of Ranbaxy's branded generic drugs from the US market.

Sun Pharmaceutical Industries Ltd which on Monday announced the acquisition of Ranbaxy Laboratories in a $4 billion deal, today said it planned to phase out sales of Ranbaxy's branded generic drugs in the United States once it completes the takeover of the loss-making rival.

The announcement comes amidst reports that a few days before Sun Pharma's acquisition of Ranbaxy, the US drug regulator US FDA had inspected Ranbaxy's R&D centre at Gurgaon and its clinical research (bioequivalence and bioavailabilty) centre at Terapia, Romania and cleared the two facilities.

Sun Pharma plans to gradually rebrand Ranbaxy drugs sold in the US as Sun Pharma treatments as part of a strategy to turn around the company after the buy-out from Japan's Daiichi Sankyo Ltd.

The Ranbaxy brand is likely to continue in other markets, sources said.

Sun Pharma had said it would fix quality glitches that barred Ranbaxy's India-made drugs from the United States and forces Daiichi Sankyo to sell it off.

Sun Pharma said Ranbaxy brand has a brand value and that it would find ways of using it and preserving it.

Alongside the phase-out of Ranbaxy brand in the US, Sun Pharma also plans intense lobbying push with the US FDA to lift ban on exports from Ranbaxy's India plants over production quality concerns.

Meanwhile, exports to EU from Ranbaxy's two plants to remain suspended and the European Medicines Agency (EMA) said Indian authorities have withdrawn certification to the Toansa plant, while an international inspection of the Dewas plant has been planned for June 2014.

EMA sources said the EMA and national medicines authorities in the EU are progressing with their assessment of reports of non-compliance with good manufacturing practice (GMP) at two Ranbaxy Laboratories' sites in India.

Ranbaxy had voluntarily suspended exports from the sites to the EU in January 2014. The EMA said a second unannounced international probe of the Toansa site was conducted after the USFDA banned products from the plant in January. The preliminary findings of the inspection carried out jointly by authorities from Germany, the UK, Ireland, Switzerland and Australia did not highlight any additional issues beyond those already identified.

The Toansa site had been supplying APIs for four centrally authorised medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) - and several non-centrally authorised medicines in Europe.