Zydus receives EIR for the Ambernath API manufacturing facility

Zydus has received the EIR report from the USFDA for the inspection conducted at its API manufacturing facility located at Ambernath, Maharashtra. This facility underwent an inspection from 10th to 14th February 2025, and had ended with NIL observations. The EIR report has classified it as No Action Indicated (NAI).

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA

CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has obtained marketing authorisation from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Zefylti, its filgrastim biosimilar version. Earlier in February 2025, Zefylti has received the marketing authorisation in the European Union from the European Commission (EC). This is CuraTeQ’s second biosimilar to be approved by MHRA after the approval of Bevqolva in December 2024.