U.S. Blocks Import Of Ranbaxy Drugs

FDA has blocked entry into the U.S. of drugs made at two Ranbaxy Laboratories manufacturing plants in India. The order affects Ranbaxy facilities in Dewas and Paonta Sahib that make antibiotics and other pharmaceuticals in bulk or finished-dosage forms.

FDA inspectors found that Ranbaxy's procedures for maintaining production process records at the two facilities did not comply with current Good Manufacturing Practices. At the Dewas facility the agency also found that there was a risk of cross-contamination of the various pharmaceuticals made there.

In 2006, FDA had issued a sternly worded warning letter to Ranbaxy concerning manufacturing practices at Paonta Sahib. Ranbaxy said in a statement that it will address FDA's latest concerns.

The retinitis drug ganciclovir, made at the Dewas site, will still be allowed into the U.S. because Ranbaxy is its sole supplier.

In June, Japan's Daiichi Sankyo announced that it would acquire Ranbaxy for $8.2 billion. Daiichi said in July that it still planned to acquire Ranbaxy despite the firm's deepening regulatory problems. Daiichi's assurance followed an announcement by the U.S. Department of Justice that it was initiating an action against Ranbaxy for manufacturing adulterated and misbranded drugs (C&EN, June 16, page 14).