Opocrin is among the first companies worldwide to receive U.S. approval for a molecule used to treat severe anemia, marking Opocrin Group’s entry into the world’s leading pharmaceutical market
Opocrin S.p.A. has obtained approval from the U.S. Food and Drug Administration (FDA) for the commercialization of Iron Sucrose in the United States, marking the official entry of Opocrin Group into the U.S. pharmaceutical market. This represents a highly significant milestone in the Group’s international development path, achieved in collaboration with the Greek company Rafarm as co-developer. Opocrin is among the first companies worldwide to receive authorization to access the U.S. market with Iron Sucrose, an active pharmaceutical ingredient used in the treatment of severe forms of anemia.
Through this approval, Opocrin Group further expands its portfolio, strengthening the supply of this injectable molecule in the United States and contributing to improved access to a therapy that is essential for millions of patients.
The FDA authorization therefore represents a key step in Opocrin Group’s evolution toward an increasingly integrated and international pharmaceutical company.
Commenting on the achievement, Federico Saetti, Chief Executive Officer of Opocrin Group, stated:
“Entering the U.S. market, particularly with a product that can be life-saving for certain conditions, clearly defines what Opocrin Group has become. We place the patient at the center, enabling broader access to essential therapies through complex medicines developed within regulatory frameworks with the highest standards. We are also continuing the transformation journey that began in 2021, evolving from an active pharmaceutical ingredients company into an international pharmaceutical company, with the health and well-being of patients as our top priority.”
