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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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