Adalvo announces positive progress in our Dydrogesterone 10mg tablets project.
Our DCP is in pre-assessment and we are positioned to be one of the first players to secure the first EU generic approval, with an immediate launch opportunity upon MA approval.
Developed based on the reference brand Duphaston, Dydrogesterone is indicated for the treatment of progesterone deficiency and hormone replacement. The INN sold around $501 million in 2023, with a 3-year CAGR of 6%, according to IQVIA.
Dydrogesterone is manufactured in a state-of-the-art R&D facility, with several GMP inspections already completed. Crucially, Adalvo has secured a reliable API supplier for Dydrogesterone, addressing the challenges posed by the limited number of API suppliers in the market.
As we press forward with our DCP submission for Dydrogesterone Tablets, Adalvo continues to invest in its women’s portfolio.
At Adalvo, there are no half-measures – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.
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