Ranbaxy signs consent decree with US FDA over production practices

India’s largest drugmaker Ranbaxy Laboratories (RANB: BO), which is 64% owned by Japan’s Daiichi Sankyo, has signed a consent decree with the US Food and Drug Administration, committing to further strengthen procedures and policies to ensure data integrity and to comply with current Good Manufacturing Practices. The consent decree is subject to approval by the US District Court for the District of Maryland.

Ranbaxy has been prevented from selling some of its products in the USA since the FDA banned the import of more than 30 of the firm's generic drugs in 2008, citing poor quality at two production facilities in India. In 2009, Ranbaxy also received a warning letter from the FDA about manufacturing standards at its facility in Gloversville, New York. The settlement with the FDA has raised hopes that the ban on Ranbaxy exporting drugs to the USA from two manufacturing facilities in India that have been found in breach of GMP rules.

Makes $500 million provision, leading Daiichi to slash profit forecast