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Adalvo announces successful DCP Submission for Mirabegron

26 June 2023

We are pleased to announce our successful DCP submission for Mirabegron prolonged release tablets. 

This product has been developed in collaboration with one of our strategic partners, based on the reference brand, Betmiga prolonged release tablets.  It is indicated in the treatment of urgency, increased micturition frequency and urgency incontinence.

The brand sold approximately $3130 Mn globally in 2022, with a Global 3Y CAGR of 5%, according to IQVIA.

Based on these regulatory submissions, Adalvo expects to obtain marketing authorisations that will be made available for our partners.

Adalvo is one of the few Companies able to complete this very difficult development of a complex product in the generic pharma space, which further showcases our ability to bring differentiated products to our partners, strengthening Adalvo's presence in the Urology segment.

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At Adalvo, there are no half measures – we arealways on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. – Central & Eastern Europe, Russia & CIS North Europe, APAC, MENA & Israel – Brazil LATAM (exc. Brazil) & South Europe – Europe – UK/Ireland, North America & South Africa - Head of Global BD&L

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