Another Indian facility run by Ranbaxy Laboratories Ltd has been hit with a manufacturing and distribution ban on active pharmaceutical ingredients (APIs) for drugs approved in the United States. The U.S. Food and Drug Administration (FDA) has added Ranbaxy's Toansa plant to the list of Indian facilities included on the consent decree dated January 2012.
Under the terms of the decree, Ranbaxy has to ensure that its manufacturing practices at the Paonta Sahib, Dewas and Mohali plants are brought up to current standards. The Indian drug manufacturer is also required to resolve data integrity issues at the Paonta Sahib and Dewas sites.
The FDA concluded its inspection of the Toansa plant on Jan. 11, 2014. The regulator said it had found significant violations of CGMP (current good manufacturing practice) standards. Specific examples include repeat tests on raw materials, intermediate drug products and finished APIs after their failure to meet specifications. The staff re-tested the items to produce acceptable findings and did not report or investigate the failures, the FDA said.
The regulator's decision means that the U.S. market is closed to drugs containing APIs made in Toansa, including products Ranbaxy manufactures at its Ohm Laboratories in New Jersey. The Indian company is also prohibited from supplying Toansa-made APIs for use in FDA-approved drugs or exporting such APIs to the United States for any purpose. The ban also covers the provision of Toansa-manufactured APIs to other companies distributing their products in the United States.