Dr Reddy’s: FDA to inspect Mexico plant in March

Dr Reddy’s: FDA to inspect Mexico plant in March

March 20th, 2012 // 2:35 pm @

Dr. Reddy’s Laboratories Ltd. said it has been informed of an inspection by the U.S. Food and Drug Administration of its Mexico facility during the last week of this month.

The drug regulator had in June last year banned imports into the U.S. of some active pharmaceutical ingredients and steroids made at Dr. Reddy’s Mexico unit, citing violation of manufacturing practice rules.

The company, in a filing with the U.S. Securities and Exchange Commission Monday, also said it is working collaboratively with the FDA to resolve the regulatory issues concerning the Mexican facility.

The Mumbai- and New York-listed drug maker has been in talks with the U.S. drug regulator for some time now to get it to lift the import ban, which would happen once the FDA has inspected the facility and found that the issues have been resolved to its satisfaction.

The Mexico facility, which produces drug ingredients and intermediates, is part of Dr. Reddy’s pharmaceutical services and active ingredients business.

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