Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, has proudly announced the acquisition of a wholesale license granted by the New Jersey Department of Health (NJDOH), allowing the company to function as a virtual manufacturer. The attainment of this wholesale license stands as a pivotal requirement for ITM’s operations in the United States, positioning the company to distribute its radiopharmaceutical products and enhance patient access upon approval by the U.S. Food and Drug Administration (FDA).
Establishing its U.S. headquarters in Princeton, New Jersey in April 2023, ITM strategically prepared for potential market registration of its targeted radiopharmaceutical pipeline product candidates and promptly applied for the wholesale license. Following a thorough inspection by regulatory bodies that identified no deficiencies, ITM was officially granted the wholesale license on January 16, 2024.
Steffen Schuster, CEO of ITM, emphasized the significance of obtaining the wholesale license, stating, “This milestone is a crucial advancement in expanding our U.S. operations, aligning with our preparations for the future launch of both diagnostic and therapeutic radiopharmaceutical products in this important market. With this license in hand and our dedicated U.S. team, we are well-positioned to strengthen our capabilities in serving the global healthcare community, our valued partners, and, most importantly, patients.”
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