The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route

 
• By Anju Ghangurde

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Firms Await Regulatory Inspections
Indian Firms Face Limited Visibility In Inspection Schedules • Source: Alamy

More from Strategy

More from Business