Ranbaxy may shift key drug filings from Mohali to US

NEW DELHI: Ranbaxy Laboratories may consider plans to shift some of its drug filings from its Mohali plant to its US-based Ohm Labs facility, after the former was barred from exporting drugs to the US market last month, analysts feel.


A company spokesperson refused to comment on whether it is planning to shift its key drug filings from Mohali to US-based Ohm Labs.

The company has over 30 Abbreviated New Drug Applications (ANDAs) filed since 2009 from the two facilities combined, with estimated brand sales of over $6 billion in the US market. Filings from Mohali outnumber filings from Ohm facility, according to industry executives.

Considering its US facility is already running chock-a-bloc, analysts feel, the company may cherry-pick and transfer its first to file ANDAs such as generic Valcyte and Nexium to Ohm, if it hasn’t done so already.

Ranbaxy was expected to launch the first generic equivalent of Roche’s Valcyte (valgancyclovir HCL), which has annual sales of $195 million in the US, in September 2013.

Ranbaxy’s next test would be the launch of generic version of AstraZeneca’s Nexium (Esomeprazole magnesium), which commands sales of over $5 billion, expected early next year. “They can only move select filings to the US facility, because of capacity constraints there. The process of shifting and getting drug approval from US regulator would take a minimum of six months and would mean incurring additional costs in form of fresh stability tests the company would have to undertake,” said Ranjit Kapadia, senior vice president, Centrum Broking. Even if some critical filings are transferred, it would be at the cost of some less remunerative products Ranbaxy is already selling in the US market.

“There is an increased danger to the base business growth even if Ranbaxy is able to launch key first to file (drugs) in calendar year 2014, since Ohm facility might face capacity constraints as it is presently running at full capacity,” reckoned Ashish Rathi of Emkay Global.