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U.S. FDA Clears Mexico Site For Dr. Reddy’s As Company Nears Goal of $3 Billion In Sales

This article was originally published in PharmAsia News

Executive Summary

A slew of launches and growth in emerging markets will have to counter an increasingly tough U.S. market

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U.S. FDA Slams Warning Letter On Dr. Reddy's For GMP Violations At Mexico API And Steroids Site

MUMBAI - U.S. FDA issued a warning letter to India's Dr. Reddy's Laboratories Ltd. following investigations that detected adulterated APIs at its Cuernavaca, Mexico site. The regulatory agency noted "significant deviations" from current good manufactuirng practices at the site. The FDA probe centers around unvalidated analytical methods, deficiencies in handling out-of-specification investigations and parameters used to ensure cGMP compliance

Dr. Reddy's To Close Atlanta Facility In Reorganization; Focus On Key Markets To Drive Revenues To $3 Billion By 2013

MUMBAI - Need for optimization of infrastructure and resources, falling productivity and spiraling cost of discovery research has led Dr. Reddy's Labs, one of India's largest drug companies, to integrate its drug discovery operations with Aurigene - a partnership-based discovery biotech unit that it owns in Bangalore

Indian Investors Turn Cautious On Compliance Concerns

A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.

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