Drug Approval | November 13, 2024
EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
CuraTeQ and Orion had entered into a licensing agreement, granting marketing and distribution rights for CuraTeQ’s biosimilar products under development in the Nordic states, Austria, Hungary and Slovenia
CuraTeQ Biologics is on track for filing a second oncology biosimilar
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