Nexium pills made with an ingredient from an Indian plant that failed regulatory inspections are safe to use and haven’t been removed from the U.S. marketplace, AstraZeneca Plc (AZN) said.
Nexium, the acid-reflux medicine, generated $3.9 billion in sales last year as AstraZeneca’s second best-selling drug. While the company previously bought a key ingredient for Nexium sold in the U.S. from Ranbaxy Laboratories Ltd. (RBXY) in India and Minakem SAS of France, it switched to the French company as sole supplier after regulators banned Ranbaxy in January from sending products from the plant to the U.S.
The quality of drugs made in some of India’s plants has come under scrutiny after the Food and Drug Administration blocked four from sending products to the U.S., and the agency’s commissioner promised to expand inspections there. AstraZeneca hasn’t found any problems with Nexium’s quality, said Vanessa Rhodes, a spokeswoman for the London-based drugmaker. Rhodes declined to say what steps the company took to test the product.
“Assuring the safety and quality of our medicines is our No. 1 priority,” Rhodes said by e-mail. “As we would in response to any regulatory action of this sort, we have carried out rigorous quality-control checks to ensure U.S. Nexium meets our quality standards.”
Many consumers don’t realize that brand-name drugs made by large pharmaceutical companies may contain ingredients from Indian plants, said Dirk Rodgers, who runs a consulting firm that specializes in health-care supply chains.
“You and I may have both taken Ranbaxy drugs in the past 10 years,” he said. “You don’t connect the name of the company with the drug you are taking.”
Inspectors banned imports from Ranbaxy’s factory in Toansa, India, because it found workers there had retested drug products to produce acceptable findings after the items originally failed analytical testing.
Nexium sold in the U.S. is made at locations in the U.S. and Sweden, Rhodes said. Prior to the FDA ban on the Toansa plant, the active ingredient, esomeprazole magnesium, was supplied by both Ranbaxy and Beuvry-la-Foret, France-based Minakem, she said.
AstraZeneca agreed in 2008 to buy esomeprazole magnesium from Ranbaxy, the companies said at the time. The companies announced on the same day the settlement of a lawsuit. AstraZeneca had sued Ranbaxy for alleged patent infringement after the Indian company applied to the FDA for approval of a generic version of Nexium.
The contract to use the active ingredient from Ranbaxy expires in May, Rhodes said. Nexium loses patent protection in the U.S. in May, and several generic companies have licenses to begin selling copies of the drug beginning May 27, AstraZeneca said last month.
The FDA has banned Ranbaxy from making or distributing drug ingredients from four plants in India. The latest to be banned, Toansa, makes a “huge part” of Ranbaxy’s active pharmaceutical ingredients, the drug components it uses to formulate medicines and sell to other drug companies, Barclays Plc said in January.
“This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation,” Arun Sawhney, Ranbaxy’s chief executive officer and managing director, said at the time.
Producers of active pharmaceutical ingredients must test their quality before distributing them, and factories that produce finished drugs must test the materials they buy before use, said Christopher Kelly, a spokesman for the FDA. In some cases, a drugmaker can rely on a supplier’s certificate of analysis, he said.
Kelly declined to comment on whether the agency has contacted AstraZeneca or other drugmakers about the use of ingredients from India.
“There is no indication that patients are at risk from taking finished drug products containing API from the Toansa facility, or from finished drug products produced at other Ranbaxy facilities also currently under the consent decree,” he said by e-mail.
Ranbaxy agreed last year to pay $500 million to resolve fraud allegations and federal criminal charges that the company sold adulterated drugs while lying about it to U.S. regulators.
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