US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures
Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
Torrent Pharma has reported a double-digit drop in its US revenues after discontinuing its sartan portfolio, due to the presence of trace amounts of N-nitrosodimethylamine. The company saw its domestic market grow aided by market share gains in high potential new launches.
Torrent has tempered US growth expectations while it plans to put its Dahej, Indrad and Levittown plants up for FDA inspection in 2020. Meanwhile, products launched in India, including remoglifozin in-licensed from Glenmark, have shown an encouraging uptake.