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Biocon Waits On FDA Insulin Inspection

Indian Company Seeks US Agency 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

Front-line Indian companies like Biocon 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 in Malaysia in the third quarter of calendar year 2021, in support of its biosimilar insulin aspart biologics license application, though investors appeared concerned

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