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Latest From Lupin Limited
Lupin CEO Vinita Gupta has insisted that additional incentives are necessary to make local manufacturing in the US viable. The recently-launched podcast by the US Association for Accessible Medicines, with CEO Dan Leonard as the host, welcomed Gupta who shared details of Lupin’s strategy and how the company plans to keep a firm foot in affordable medicines.
Keeping Track: US FDA Approval Of Jazz Rylaze Addresses Shortage; MediWound, Cyclopharm Receive CRLs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Lupin insists it has a “comprehensive remediation plan” to address deficiencies identified at its Novel Laboratories facility in New Jersey by an FDA warning letter. The Indian company says it does not anticipate any near-term commercial impact or supply disruptions linked to the letter.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
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