Getting FDA approval of a new plant in India meant Ranbaxy Laboratories ($RANBAXY.NS) was able to push out enough generic Lipitor in March to take the top spot in production of the world's top drug.
According to market research firm Wolters Kluwer Pharma Solutions, Ranbaxy produced 17.5 million atorvastatin doses last month, edging out Pfizer ($PFE), which dispensed about 17.2 million branded pills, The Wall Street Journal reports. Watson Pharmaceuticals ($WPI), which makes an authorized generic, sold 10.8 million tablets.
After a four-year stint of being unable to ship drugs from its plants in India to the U.S. and Canada, Ranbaxy Laboratories last week announced it was shipping its version of Lipitor to the U.S. and moving additional production to markets in Europe. The FDA gave the green light to the new plant in October.
Manufacturing problems at Ranbaxy came to light in 2009 and led to bans of drugs from certain facilities in India and elsewhere. Issues were extensive, including giving the FDA falsified data. In January, Ranbaxy, which is owned by Daiichi Sankyo in Japan, signed a consent decree with the Department of Justice with input from the FDA.
Analysts have pointed out that the added production from the new plant means Ranbaxy needs to be selling a lot more of the drug. It is already shipping supplies to Germany, Italy, Sweden and the Netherlands. At least for March, it had roughly 39.1% of the world market, Pfizer had 38% and Watson 23.7%.
- here's the WSJ story