Torrent’s Entry Into Indian Trade Generics Signals Strategy Shift
US Launches Still Held Back
Faced with a slowdown in the US from a lack of regulatory approvals, Torrent Pharma is looking at alternate growth strategies. Its entry into the trade generics segment in India, joining other pharma majors, is one to be watched as it marks a strategic shift.
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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.
Torrent has reached a settlement with BMS’ Celgene over oncology blockbuster Revlimid, officials said during a Q2 call, but declined to disclose launch timelines for the generic. Meanwhile, the Indian company continues to evaluate an option to enter the injectables segment in the US as revenues slide.
The US FDA conducted seven drug inspections in India from February through August 2021 and front-line Indian firms are hopeful things will pick up further and that some pre-approval inspections may happen virtually. But no foreign surveillance inspections are expected to be conducted by FDA inspectors traveling from the US before September 2021.