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The Factory Floor: Biocon Celebrates Malaysian Insulin Plant Clearance

As MedPharm And Lupin Successfully Complete FDA Inspections

Executive Summary

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.

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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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