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Re: JFR161162 post# 804686

Saturday, 12/27/2025 9:04:31 AM

Saturday, December 27, 2025 9:04:31 AM

Post# of 817836

If they had production issues at Avent, why the 2 licences were renewed 10 days ago?


This has been explained many times.

The MIA certifies that Advent can manufacture to GMP standards, It does not say they are certified to manufacture a specific drug/biologic. For the latter they must demonstrate the manufacture the specific product to the standards defined by the MAA./BLA

Any approved drug/biologic lists the facilities that have been approved for manufacturing that specific agent.
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