- Charles River Laboratories ( NYSE: CRL ) on Tuesday said it had got a good manufacturing practice certification from Europe's drug regulator to commercially produce and distribute allogeneic cell therapy drug products.
- CRL said the approval came after an inspection of its Memphis facility by the cell and gene therapy experts from the Italian inspectorate AIFA performed on behalf of the European Medicines Agency.
- CRL said the Memphis contract development and manufacturing facility (CDMO) could now make and ship drug products for distribution in the European Union.
- CRL last week reduced its FY 2022 due to headwinds associated with its CDMO business, foreign exchange and interest expenses, sending the stock down ~9% .
- Shares of Charles River ( CRL ) closed -1.2% at $220.68 on Monday.
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Charles River gets EU nod to commercially make, distribute cell therapy drug products