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US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Executive Summary

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

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Torrent Sees Decline In US Sales After Dropping Sartan Portfolio

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.

Regulatory Overhang Hurts Torrent

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.

Torrent Sees Fortunes Affected By Regulatory Overhang

Torrent has tempered FY21 US growth expectations while it plans to put 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.

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