FDA bans second Wockhardt plant
FDA Commissioner Margaret Hamburg is slated to travel to India soon, and she will have lots to talk about--like all of the Indian plants the FDA has banned from exporting to the U.S. The agency Tuesday hit a second Wockhardt facility with a so-called import alert that prevents it from selling products into the U.S.
The ban was placed on a Wockhardt plant in Chikalthana, a facility the U.K. had already banned from selling there after inspectors found issues with the facility. According to Reuters, the FDA is allowing the company to continue to sell 5 products made at the plant but banned the rest. Among its products is a generic version of AstraZeneca's ($AZN) hypertension drug Toprol. Reuters said the facility generated $230 million in U.S. sales in Wockhardt's last fiscal year. The U.S. has been the company's largest market and accounted for about 43% of its revenues.
The company said in a statement that it was taking steps to resolve the issues. It did not say what the nature of the problems were.
The FDA in May issued a ban against a plant in Waluj, in which Inspectors accused plant quality-assurance personnel of hiding records and not giving the FDA access to all of the areas of the facility that manufactures products for the U.S. It also found standing urine in a bathroom and mold near the sterile manufacturing area. The company told investors that the FDA is allowing it to continue to import its enalapril product, a generic of the blood pressure med Vasotec, that it manufacturers there from that facility, but it has said lost revenue from that ban will cost it $100 million.
Wockhardt, of course, is not the only Indian drugmaker to face import bans. The FDA in September imposed the ban on Ranbaxy Laboratories' plant in Mohali, India, after inspectors found rampant problems. The drugmaker's other two Indian plants that had sold into the U.S. were put on import alerts in 2008. Ranbaxy in May agreed to pay the U.S. $500 million to settle for problems uncovered at those facilities, but they remain unable to supply the U.S. With the Mohali ban, Ranbaxy now has only its plant in New Jersey approved for sales in the U.S., a market that had provided 40% of its revenues.
Hamburg is slated to travel to India yet this year or early next year for the first time in her tenure as FDA commissioner. The agency has been marshalling resources there, adding inspectors and a new head of the FDA office, Altaf Ahmed Lal, an Indian-born Ph.D. India is essential to drug production for the U.S., making a large part of the generic drugs that U.S. consumers are prescribed, but many companies have had problems with meeting quality standards. Lal has said that working with manufacturers there on quality is one of his top priorities.
- here's the Reuters story
FDA beefs up Indian staff in face of serious problems
India's plan to inspect China plants stalled
FDA bans suck sales out of Ranbaxy, Wockhardt
Possible hair in tablet one of rampant problems at Ranbaxy plant
U.K. takes enforcement action against third Wockhardt plant
FDA excoriates Wockhardt over missing records, standing urine