Having reached near capacity at its Ohm plant in New Jersey, much of Ranbaxy Laboratories' future production for the U.S. and Europe will come from its plant in Mohali, India.
"There are more approvals coming through and will come through from Mohali facility because quite a bit of our regulatory submissions in the recent times have gone from Mohali," Ranbaxy CEO Arun Sawhney said in a briefing after the release of Ranbaxy's earnings last week, according to The Economic Times.
The plant early this year was approved to manufacture Ranbaxy's copycat of Pfizer's ($PFE) Lipitor and the company began shipping that drug to the U.S. and Canada in March. North American sales, powered by generic Lipitor, were up 140% for the latest quarter and provided the best news out of a quarter in which Ranbaxy posted a loss of 5.86 billion rupees, ($106 million), which it tied to a weak rupee, Reuters reports.
Executives of Ranbaxy, which is controlled by Japan's Daiichi Sankyo, said the Mohali plant will manufacture tablets, capsules and dry syrups for the U.S., EU and Japan and other regulated markets. Because it is one of the companies' FDA-approved plants, the Mohali plant is covered by the consent decree with U.S. regulators early this year after Ranbaxy was discovered faking data on its drug applications. As part of the agreement, Ranbaxy was ordered to set up an Office of Data Security to investigate and certify that data with applications are accurate.
Another provision of the 55-page consent decree, considered the most sweeping ever imposed on a drugmaker, is that Ranbaxy had to forfeit the 6-month exclusivity on three unidentified drugs for which it had approved applications. Analysts believe that one of those must be a copy of Teva Pharmaceutical Industries' ($TEVA) blockbuster Provigil and estimated that it is costing Ranbaxy up to $100 million in sales to sit this one out. "The market has assumed that they have given up on the exclusivity of this product," Surajit Pal of Elara Capital told the The Economic Times last week.
- read the Economic Times story
- here's the Reuters story
- here's the consent decree
Company whistleblower program part of Ranbaxy consent decree
Ranbaxy faces 'groundbreaking' oversight with DoJ settlement
Teva's Provigil may be one Ranbaxy forfeited in consent decree
Ranbaxy manufactures a colossal first quarter