The U.S. Food and Drug Administration took another action
against Ranbaxy Laboratories Ltd. on Thursday, prohibiting it from
making or selling drug ingredients from its Toansa, India, plant
for the U.S. market.
Ranbaxy, an Indian unit of Japan's Daiichi Sankyo Co., has been
a major supplier of drug ingredients to the U.S.--especially for
generic drugs--but has come under FDA scrutiny of late.
The federal agency said Ranbaxy was blocked from distributing
any drug raw materials in the U.S. from the Toansa facility.
Ranbaxy also is blocked from making raw ingredients from Toansa
available to other companies for sale in the U.S., the FDA
said.
The FDA said it didn't immediately have a full list of drugs
made at the plant. Ranbaxy officials weren't immediately available
for comment.
The FDA action followed inspections of the Toansa plant by the
U.S. agency between Jan. 5 and Jan. 11. The FDA said Ranbaxy
staffers retested raw materials after they failed earlier tests "in
order to produce acceptable findings," and that the staffers didn't
investigate the failures.
Ranbaxy is a major supplier of raw materials for the generic
drug market. The FDA said it didn't know of any immediate shortages
that would be triggered by its action, but it said it "may modify"
the order if a medically necessary drug is in short supply because
of it.
In January 2012, Ranbaxy reached a consent decree with the U.S.
Department of Justice over manufacturing quality issues. The decree
required the company to take steps to ensure the integrity of
production at three plants, at Paonta Sahib, Batamandi and Dewas,
India, as well as at the company's unit in Gloversville, N.Y.
In September, the FDA also blocked imports from Ranbaxy's newest
plant, at Mohali in northern India.
Ranbaxy has five manufacturing facilities in India that are
registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon and
Dewas. Gurgaon isn't currently producing drugs for the U.S. market.
The other four facilities--Paonta Sahib, Mohali, Toansa and
Dewas--are all now covered under the consent decree.
Write to Thomas M. Burton at tom.burton@wsj.com
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