Data Integrity Concerns Halt IPCA’s U.S. Exports
This article was originally published in PharmAsia News
Executive Summary
Mumbai-based IPCA Laboratories is the latest casualty in a long series of data integrity issues that have crippled Indian drug companies. IPCA said it received observations from the U.S. FDA on its API site based in Central India and pending complete remediation, it will voluntarily halt exports to the U.S.