Corporate Announcement
Security Code : 524804    Company : AUROPHARMA    
Withdrawal Of Applications For EU Marketing AuthorisationsDownload PDF 0.19 MBDownload XBRL
  Exchange Received Time  25/06/2023 18:06:19         Exchange Disseminated Time   25/06/2023 18:06:20              Time Taken   00:00:01
Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, this is to inform you that: M/s. CuraTeQ Biologics s.r.o.'s, a wholly owned step-down subsidiary of the Company, request to withdraw the applications for Marketing Authorization of ZEFYLTI (a filgrastim biosimilar) and DYRUPEG (a pegfilgrastim biosimilar) has been accepted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA as we will not be able to obtain EU-GMP certification of our biosimilars manufacturing facility within the current Day 180 clock stop period and no further clock-stop extensions would be possible at this stage of the review procedure by CHMP. We will be working with the Agency to re-submit these applications at the earliest.


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