Latest news
- Business18 July 2024
Adalvo Announces Early European Approval for Empagliflozin Film-Coated Tablets
Adalvo announces the successful earlier-than-expected DCP approval for Empagliflozin 10mg and 25mg film-coated tablets. Our product has been developed based on the reference brand Jardiance film-coated tablets, which are indicated for...
- Business15 July 2024
Adalvo Restarts DCP Procedure for Dapagliflozin Film-Coated Tablets
Adalvo announces the restart of the DCP procedure for Dapagliflozin Film-Coated Tablets, with an anticipated EU Marketing Authorisation approval date in October 2024. Developed based on the reference brand Forxiga film-coated...
- Business12 July 2024
Adalvo Announces Successful DCP Submission For Empagliflozin/Metformin Film-Coated Tablets
Adalvo announces the successful DCP submission for Empagliflozin/Metformin film-coated tablets, with an anticipated approval date in June 2025. Developed based on the reference brand Synjardy film-coated tablets, Empagliflozin/Metformin is indicated for...
- Business10 July 2024
Adalvo Secures DCP Approval for Apixaban Tablets
Adalvo announces the successful DCP approval for Apixaban Tablets. Based on the reference brand Eliquis, Apixaban is indicated for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)....
- Business03 July 2024
Adalvo Expands Portfolio with Voclosporin Soft Gel Capsules
Adalvo announces the addition of Voclosporin 7.9mg Soft Gel Capsules to its portfolio. Based on the reference brand Lupkynis, Voclosporin is indicated for treating adult patients with Lupus Nephritis (LN). Voclosporin represents the...
- Business02 July 2024
Adalvo Successfully Completes Pivotal BE Study for Azacitidine Film Coated Tablets
Adalvo announces the successful completion of the Pivotal BE study for Azacitidine 300mg film-coated tablets in adult patients with acute myeloid leukaemia (AML). Following the successful EU Pivotal BE study, Azacitidine...
- Sustainability01 July 2024
Embracing the Night: Deniz Kayadelen's Bold Journey to Conquer the Catalina Channel and Raise Awareness for Clean Water
As Deniz Kayadelen, Adalvo’s Brand Ambassador, prepares for her upcoming swim across the Catalina Channel on July 21st, we are reminded of the immense mental and physical challenges she faces....
- Business27 June 2024
Adalvo Prepares for Rapid Filing of Fidaxomicin
Adalvo advances in the development of Fidaxomicin Film Coated Tablets 200mg, expecting dossier completion within the next six months. Following this, Adalvo intends to immediately file Fidaxomicin, having DCP slots already secured for...
- Business24 June 2024
Adalvo Introduces Olaparib Film Coated Tablets to its Oncology Portfolio
Adalvo announces the addition of Olaparib Film Coated Tablets to its expanding oncology portfolio. As a leading PARP inhibitor, Olaparib has received the most FDA approvals across four tumor types, underscoring...
- Business20 June 2024
Adalvo Launches Rivaroxaban Film-Coated Tablets in the UK
Adalvo announces the successful launch of Rivaroxaban Film-Coated Tablets in the United Kingdom. Developed based on the reference brand Xarelto, Rivaroxaban is indicated for the prevention of atherothrombotic events in adult...
- Business19 June 2024
Adalvo’s Extensive Diabetes Portfolio - Small Molecules and Peptide Injections
Adalvo has developed one of the broadest diabetes pipelines in the industry with an extensive range of therapeutic options. Our diverse portfolio includes small molecules and peptide-based treatments, encompassing both oral...
- Business18 June 2024
Pregabalin Prolonged Release Tablets Launched in Spain
Adalvo and Gebro Pharma announce the successful launch of Pregabalin Prolonged Release Tablets in Spain, under the brand Dalingo®. This product, indicated for treating Neuropathic Pain, is set to enhance patient adherence...
- Business13 June 2024
Adalvo Secures First EU Generic Approval for Liraglutide Pre-Filled Pen
Adalvo announces the successful DCP approval for Liraglutide pre-filled pen, marking it as the first generic approval in the EU. As a bioequivalent version of Victoza® pre-filled pen, indicated for the treatment...
- Business10 June 2024
Adalvo’s Progress With Semaglutide Pre-Filled Pen
Adalvo has completed the development of Semaglutide 1.34mg/ml pre-filled pen, a generic and bioequivalent version of Ozempic®, which is indicated for treating type II diabetes. Having filed as the first company...
- Business06 June 2024
Adalvo Announces Successful Pivotal BE Study of Ambrisentan/Tadalafil Film- Coated Tablets
Adalvo announces the successful completion of the Pivotal BE study of Ambrisentan/Tadalafil Film-Coated Tablets 5mg/20mg under Fed and 10mg/40mg under Fasting conditions. With the successful completion of our initial studies, we...
- Sustainability05 June 2024
Adalvo's Commitment to ESG: Celebrating Our Efforts on World Environment Day
At Adalvo, we believe in making a positive, sustainable impact on the communities where we live and work. On this World Environment Day, we are proud to highlight our ongoing...
- Business03 June 2024
Adalvo Targets to File Ruxolitinib IR Dossier in Q4 2024
Adalvo is on target to file the Ruxolitinib Immediate Release (IR) Tablets dossier in Q4 2024. Filing upon dossier readiness, Adalvo aims to be among the first companies to launch this...
- Business31 May 2024
Adalvo announces successful European approval for Dalbavancin Powder
Adalvo announces the successful DCP approval for Dalbavancin 500mg Powder for concentrate for solution for infusion. This niche antibiotic has been developed based on the reference brand Xydalba (EU) and is...
- Business23 May 2024
Lisdexamfetamine Oral Solution: EU Approved, US Submission Upcoming
Adalvo’s Lisdexamfetamine 10mg/ml Oral Solution has secured approvals in the EU, with US submission upcoming. To our knowledge, we are the first and only company to secure approval for Lisdexamfetamine...
- Business21 May 2024
Adalvo Advances Dydrogesterone 10mg Tablets: First EU Generic Approval on the Horizon
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...
- Business17 May 2024
Adalvo Raises Awareness on Mellozzan®
Adalvo showcases Mellozzan®, an EU-approved product designed to alleviate both jet lag and ADHD-related insomnia symptoms. Mellozzan®, which contains the well-established active substance, Melatonin, is available in capsule and oral...