String Of Positives Lifts Lupin's Outlook
Regulatory Clearances For Some Key Sites Awaited
Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential European nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.
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Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.
Pharma manufacturing is operating well below normal levels in India, disrupted by labor absenteeism and supply chain issues amid the ongoing lock-down in the country, though the government is actively engaged in addressing bottlenecks. A speedy recovery is vital not just for domestic supplies.
Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.