Latest news
- Business29 November 2024
Adalvo Submits DCP for Palbociclib Tablets
Adalvo has submitted the DCP for Palbociclib film-coated tablets on Day 1 following the expiry of Data Exclusivity, reinforcing our commitment to expanding our oncology portfolio. Approval is expected in 2025. Supported...
- Business26 November 2024
Adalvo Receives DCP Approval for Azelastine/Fluticasone Nasal Spray
Adalvo has received DCP approval for Azelastine/Fluticasone nasal spray, strengthening its respiratory portfolio and meeting key market needs. This approval aligns with Adalvo’s clearly defined IP pathway, leveraging a complex, difficult-to-develop...
- Business22 November 2024
Adalvo Submits DCP for Palbociclib Film-Coated Tablets
Adalvo has submitted the DCP for Palbociclib film-coated tablets, reinforcing its commitment to expanding its oncology portfolio. Approval is expected in November 2025. Supported by Adalvo’s focused IP strategy, this submission is...
- Business14 November 2024
Adalvo Highlights Diabetes Basket with Strong IP Strategy
In recognition of World Diabetes Day, Adalvo highlights its diabetes portfolio, built with a focus on rapid market access and a strong IP strategy. Our diabetes basket spans a wide range...
- Business04 November 2024
Adalvo Receives Early European Approval For Dapagliflozin
Adalvo has received DCP approval for Dapagliflozin film-coated tablets ahead of the standard 210-day timeline, allowing strategic preparation for a Day-1 launch. Backed by a strong IP strategy, Adalvo is...
- Business01 November 2024
Adalvo launches Lisdexamfetamine in several key markets across Europe
Adalvo announces the successful multi-country launch of Lisdexamfetamine. To our knowledge, Adalvo was one of the first to introduce this differentiated product in key European markets, showcasing our industry-leading launch...
- Business30 October 2024
Adalvo and Myonex strengthen existing exclusive clinical trial supply partnership by adding multiple new assets for global markets.
Adalvo and Myonex announced today the expansion of their existing agreement, under which Myonex is the exclusive provider of Adalvo products for clinical trial use globally. Both parties have now...
- Business24 October 2024
Adalvo to Submit Palbociclib Tablets DCP
Adalvo will submit the DCP for Palbociclib Film-coated Tablets in November 2024. This submission will strengthen Adalvo’s oncology portfolio, which is backed by our robust IP strategy and aims to guarantee rapid market access....
- Business30 September 2024
Adalvo on Track to Finalize Global Fidaxomicin Dossier by End of 2024
Adalvo reports significant progress in the development of Fidaxomicin Film Coated Tablets, with the dossier on track for global submission by the end of 2024. As we gear up for the...
- Business12 September 2024
Adalvo Submits DCP Filing for Teduglutide on Day-1
Adalvo has submitted its DCP filing for Teduglutide on Day-1 following the expiry of Data Exclusivity. Teduglutide has been developed for the treatment of short bowel syndrome (SBS), a rare condition...
- Business12 August 2024
Adalvo signs an exclusive LSA with Dr. Reddy’s Laboratories, Commercialising Dalbavancin RTD in the USA
Adalvo has recently signed a licensing and supply agreement with Dr. Reddy’s Laboratories to commercialise Dalbavancin Ready-to-Dilute (RTD) in the United States. Under this strategic agreement, Adalvo will license the exclusive...
- Business09 August 2024
Adalvo Secures DCP Approval for Ethinylestradiol/Drospirenone Tablets
Adalvo announces the successful DCP approval for Ethinylestradiol/Drospirenone 0.03mg /3mg tablets. Based on the reference brand Yasmin, Ethinylestradiol/Drospirenone has been developed in collaboration with one of our strategic partners. The INN is a...
- Business06 August 2024
Adalvo Successfully Launches DMF Across Global Markets
Adalvo has successfully launched Dimethyl Fumarate (DMF) across various markets, serving over 20 partners on three continents. Dimethyl Fumarate 120mg and 240mg hard capsules have been developed based on the reference brand Tecfidera,...
- Business29 July 2024
Adalvo Launches First and Only Pregabalin ER in Europe
Adalvo has successfully launched the first and only Pregabalin Extended-Release (ER) tablets in Europe. This differentiated product has been introduced in two major European markets, Germany and Spain, through partnerships...
- Business26 July 2024
Adalvo Announces Successful EU Approval for Mirabegron 50mg Prolonged-Release Tablets
Adalvo secures successful DCP approval for Mirabegron 50mg prolonged-release tablets. Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency, and/or...
- Business24 July 2024
Adalvo Launches Desmopressin ODT in Europe, First and Only Generic Alternative Since March 2024
Adalvo successfully launched the first and only Desmopressin Orally Disintegrating Tablets (ODT) in Europe in March 2024. Developed based on the reference brand Minirin Melt, Desmopressin ODT is indicated for the...
- 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...