Germany Bars Antibiotic Cephalosporin From Ranbaxy Laboratories's Madhya Pradesh Plant
December 3, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Germany’s drug regulatory body has issued a “non-compliance” report to India-based Ranbaxy Laboratories, barring the company from exporting the antibiotic cephalosporin to Germany. The ban specifically focuses on a manufacturing facility in Madhya Pradesh.
After an inspection in June 2014, the European Medicines Agency reported on Nov. 26 that the citation is for not complying with “standard manufacturing practices.”
In a related report by the U.S. Food and Drug Administration, Ranbaxy’s factories in Dewas and others in India were barred from exporting to the U.S. for the same issues. In January 2014 the FDA published a decree that prohibited Ranbaxy’s Toansa, India facility from manufacturing and distributing active pharmaceutical ingredients (APIs) for FDA-regulated drug products.
The decree banned Ranbaxy from distributing APIs from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories in New Jersey, manufacturing API at its Toansa facility for any FDA-regulated drugs, from exporting API from Toansa to the U.S. for any purpose, and providing API from Toansa to other companies that make products for American consumers.
“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research in a statement. “The FDA is committed to ensuring that the drugs American consumers receive—no matter where they are produced—meet quality standards and are safe and effective.”
Ranbaxy has had a number of run-ins with U.S. regulations. In November of this year the U.S. FDA revoked Ranbaxy’s approval to manufacture generic versions of AstraZeneca ’s heartburn medication Nexium after its Indian facilities were cited for quality control problems. The FDA banned all of Ranbaxy’s India-based plants.
“Withdrawal of the tentative approval for Nexium provides enough room for suspicion that Ranbaxy is losing the Nexium exclusivity,” said Surya Patra, a pharmaceutical analyst with Phillip Capital, in a CNBC article.
The U.S. market accounts for about 50 percent of Ranbaxy’s revenue. In 2013 and part of 2014 Germany sales accounted for about 2 percent of the company’s revenues. Ranbaxy recently received approval from the Indian government to be acquired by India-based Sun Pharmaceuticals. Sun, however, is having its own share of problems with the U.S. FDA, with recent reports of fraudulent quality control reports on products headed for the U.S. market.