AstraZeneca Says Nexium Is ‘Still Safe’ With Ranbaxy Ingredient
AstraZeneca (NYSE:AZN) says that Nexium pills made with an ingredient produced in an Indian plant that didn’t pass regulatory inspections is still safe to use. The drug has not been recalled, according to a Bloomberg report issued Friday. Nexium is an acid-reflux medicine that generated $3.9 billion in sales last year, and it is London-based AstraZeneca’s second best-selling drug.
AstraZeneca has been buying one of the key ingredients in Nexium from a plant in India called Ranbaxy Laboratories Ltd. In January, regulators banned Ranbaxy from selling products made at the plant to the U.S. due to ongoing scrutiny from the Food and Drug Administration over the questionable quality of drugs made at the plant. The agency’s commissioner has also promised to expand inspections at the Indian plant, according to Bloomberg.
AstraZeneca has since switched companies and is now sourcing the ingredient solely from a French manufacturer, Minakem SAS.
Vanessa Rhodes, a spokeswoman for AstraZeneca, said that the company hasn’t run into any quality issues with Nexium, although she declined to answer how exactly the company tested the product’s quality. “Assuring the safety and quality of our medicines is our No. 1 priority,” Rhodes said in an email to Bloomberg on Friday. “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.”
Products stemming from Ranbaxy’s plant in Toansa, India, were banned by regulators after workers there retested drug ingredients to produce passable results, even though the products initially failed analytical testing. The Ranbaxy plant previously supplied the active ingredient for AstraZeneca’s Nexium, esomeprazole magnesium, along with French company Minakem SAS, which based in Beuvry-la-Foret, France.
The Toansa plant is only the most recent of three Ranbaxy plants to be banned from exporting products to the United States by the FDA. The Toansa plant is one the largest, however, and is responsible for producing a “huge part” of Ranbaxy’s active pharmaceutical ingredients.
“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,” said Christopher Kelly, a spokesman for the FDA, regarding the Ranbaxy ban to Bloomberg.