CuraTeQ Biologics enters into agreement with STADA Arzneimittel AG
STADA will market and distribute two EMA approved biosimilars developed by CuraTeQ in select European Union territories
STADA will market and distribute two EMA approved biosimilars developed by CuraTeQ in select European Union territories
This inspection is now closed
CuraTeQ Biologics and BioFactura USA to terminate agreement mutually
The company will respond to the US FDA within the stipulated timelines
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
The transaction aligns with Aurobindo’s strategic objective to expand its U.S. manufacturing footprint by enhancing its existing domestic capabilities
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