Torrent Sees Decline In US Sales After Dropping Sartan Portfolio
As Company Continues To Grow Domestically
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.
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Torrent expects US FDA’s final approval for Allergan/Almirall’s Aczone, a dapsone formulation for acne vulgaris, in February, even as it awaits regulatory clearance for manufacturing sites. Meanwhile, it has launched molnupiravir in India and is hiking its domestic sales force by 400-500.
The generics industry struggled with the prior-year comparison as it saw an expected decline in revenues in the first quarter of 2021, driven by the global impact of the COVID-19 crisis. As a result, the performance of most companies fell short of the numbers reported in Q1 2020. However, a few managed to contradict the trend by reporting growth, either based on the launch of COVID-related drugs or performance in specific geographies.
The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.