Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route

Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but 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.

Indian Firms Face Limited Visibility In Inspection Schedules • Source: Nielsen Hobbs

Front-line Indian companies like Biocon, Ltd. have a lot riding on regulatory inspections going through as scheduled amid pandemic-related travel restrictions to countries where plants are located.

The Bengaluru-based firm indicated that the US Food and Drug Administration had scheduled a pre-approval inspection of its manufacturing facility...