After a four-year stint of being unable to ship drugs from its plants in India to the U.S. and Canada, Ranbaxy Laboratories ($RANBAXY.NS) is returning in a big way.
The Indian generics-maker, which this week announced the FDA had signed off on production of generic Lipitor at a new manufacturing facility in India, also is shipping generic Crestor to Canada. This is a significant turnaround for the company that several years ago became the poster child for everything critics suggested was wrong with generics made in developing countries.
Canadian regulators followed the lead of the FDA in 2009 when the U.S. regulator banned drugs from Ranbaxy's Paonta Sahib plant, and others, for a long list of production problems and for falsifying data. Some drugs sold in Canada at the time also were made at that facility.
An investigation by the FDA and the U.S. Department of Justice led to January's unparalleled consent decree. It includes the company being audited by an independent consultant that reports both to the company and to the FDA any failure to meet agreed-upon stipulations. As further emphasis of what poor quality control can cost, Ranbaxy also lost its 180-day exclusivity on three drugs and faces the threat of losing it on three more as an incentive to keep up its good work.
Ranbaxy, which is controlled by Daiichi Sankyo in Japan, says its Canadian subsidiary has been given a thumbs-up to manufacture and sell to the the Canadian healthcare system RAN Rosuvastatin tablets. Without specifying a specific manufacturing facility, the company says: "The finished dosage form was developed and will be manufactured within RLL's Health Canada-approved facilities located in India." It says the tablets will be available this week when sufficient production has been reached. It points out that sales of the branded Crestor in Canada, based on IMS data, are $742.2 million Canadian.
This week, Ranbaxy made a more public announcement about getting the FDA approval for its new Mohali SEZ manufacturing facility in Punjab, India. It said the FDA approved the plant in October and earlier this year gave approval to Ranbaxy to begin selling Atorvastatin Calcium Oral Tablets made there in the U.S. It is already selling generic Lipitor in the U.S. made at its Ohm Laboratories plants. In that release, it mentioned the plant had been approved by other regulatory agencies around the world, including Health Canada.
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