Adalvo is delighted to announce the successful DCP submission of our Dydrogesterone 10mg tablets. Adalvo takes great pride in being amongst the first wave of filers in the EU, with this dossier.
Our product has been developed based on the reference brand Duphaston and is indicated in the treatment of progesterone deficiency and hormone replacement. The INN sold around $ 468mio globally in 2022, with Global 3Y CAGR at 12%, according to IQVIA.
Dydrogesterone is being developed by our sister company, which forms part of the Aztiq group, having a state-of-the-art R&D and manufacturing facility, with several GMP inspections already successfully completed.
We are thrilled about this remarkable achievement, given the challenges and intricacies involved in developing this product.
Building on this accomplishment, we continue to expand our Women's Health portfolio. As a distinguished player in this domain, we are delighted to offer a wide range of additional products, as outlined below:
- Cyproterone + Ethinylestradiol, 2 mg + 0.035 mg
- Desogestrel, 75 mcg
- Desogestrel + Ethinylestradiol, 0.10 mg + 0.02 mg
- Desogestrel + Ethinylestradiol, 0.15 mg + 0.03 mg
- Dienogest, 2 mg
- Drospirenone + Ethinylestradiol, 3 mg + 0.02 mg
- Drospirenone + Ethinylestradiol, 3 mg + 0.03 mg
- Levonorgestrel, 1.5 mg
- Levonorgestrel + Ethinylestradiol, 0.10 mg + 0.02 mg
- Levonorgestrel + Ethinylestradiol, 0.15 mg + 0.03 mg
- Norethisterone, 5 mg
- Norethisterone + Estradiol, 0.5 mg + 1 mg
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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.
ajish.rajan@adalvo.com – Central & Eastern Europe, Russia & CIS
jose.rendueles@adalvo.com- North Europe, APAC, MENA & Israel
margarida.neves@adalvo.com – Brazil
marta.puig@adalvo.com - LATAM (exc. Brazil) & South Europe
paulo.rodriguez@adalvo.com – Europe
supreet.sharma@adalvo.com – UK/Ireland, North America & South Africa
arni.baldursson@adalvo.com - Head of Global BD&L
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.