|Ranbaxy headquarters--Courtesy of Ranbaxy|
Following years after actions by the U.S., Germany and EU regulators have banned Ranbaxy Laboratories from exporting the injectable versions of its cephalosporin antibiotics following an inspection earlier this year of the company's plant in central India.
The action comes a little more than a week after a U.S. federal judge denied Ranbaxy's request for a temporary restraining order against the FDA after the agency revoked approvals for the Indian drugmaker to produce generics of AstraZeneca's ($AZN) blockbuster Nexium and Roche's ($RHHBY) antiviral Valcyte because of its manufacturing shortcomings.
The European Medicines Agency posted a notice on its website dated Nov. 26 that Germany issued a "noncompliance" report for the Ranbaxy plant where the antibiotic was made, Reuters reported. The EU followed suit days later. The inspection of the plant in Dewas, India, was conducted in June. At that time, inspectors found issues related to the operation of drug manufacturing rooms and with sterilization procedures of equipment, the news agency said.
The Dewas plant was one of two Ranbaxy facilities that the FDA banned in 2008 when issues were first brought to its attention by a whistleblower. Last year, the Indian drugmaker paid $500 million in penalties to settle litigation with the Justice Department tied to shortcomings found at the facilities, but in the last couple of years, the FDA has banned two more Ranbaxy plants for similar issues.
In early November, the FDA yanked the approvals it had granted Ranbaxy to make generics of the two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy filed a suit in federal court, partly to force the agency to rescind its denial as well as prevent competitors Endo Health Solutions ($ENDP) and Dr. Reddy's Laboratories from making Valcyte copies after the agency gave them permission.
Ranbaxy, which has said it has been working to resolve the problems with its plants, did not respond to requests by Reuters to comment on the German inspection.
- see the Reuters story