Adalvo has submitted the DCP application for Fidaxomicin 200mg tablets, advancing its strategy to expand access to complex anti-infective therapies across key regulated markets.
This follows a recent ANDA filing in the United States, supported by positive bioequivalence (BE) results.
Fidaxomicin is based on the reference brand Dificlir® and is indicated for the treatment of Clostridioides difficile infections (CDI), a serious and potentially life-threatening condition that demands targeted, high-efficacy therapy.
According to IQVIA, Fidaxomicin achieved global sales of approximately $512 million in 2024, with a 3Y CAGR of 21%, reflecting its continued clinical value and strong market demand.
The dossier submissions in both the U.S. and EU reflect the success of a technically complex development program, involving challenging pharmacokinetic studies and a clearly defined global regulatory strategy. The project demonstrates Adalvo’s ability to deliver difficult-to-make, partner-ready antibiotics aligned with the needs of healthcare systems and commercial partners.
This dual-market regulatory progress reinforces Adalvo’s growing presence in the hospital and anti-infective space, and supports its commitment to high-barrier product execution with global reach.
To explore licensing or commercial opportunities within Adalvo’s anti-infectives portfolio, contact the team today.