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Leiner’s U.S. OTC Operations Face Regulatory, Competitive Obstacles

This article was originally published in The Tan Sheet

Executive Summary

Leiner Health Products says the process of restarting its U.S. OTC operations is complicated by Dr. Reddy's Laboratories' termination of contracts to supply ingredients it needs to manufacture OTCs

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FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

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