Ranbaxy Ranbaxy hit by FDA ban

Editor: Anke Geipel-Kern

FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market. For more details, look here...

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Ranbaxy is headquartered in New Delhi.
Ranbaxy is headquartered in New Delhi.
(Bild: Ranbaxy)

The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.

The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.

Under the decree, the FDA has issued an order prohibiting Ranbaxy from:

• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey;

• manufacturing API at its Toansa facility for FDA-regulated drug products;

• exporting API from Toansa to the United States for any purpose; and

• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

Read more about FDA´s decision