ITM Isotope Technologies Munich SE (ITM), a radiopharmaceutical biotech company, announced that the company obtained a wholesale license issued by the New Jersey Department of Health (NJDOH) in order to operate as a virtual manufacturer. Obtaining the wholesale license is a pivotal requirement for ITM’s business activities in the United States. This milestone enables the company to distribute its radiopharmaceutical products, thereby facilitating patient access to ITM’s radiopharmaceuticals upon their approval by the U.S. Food and Drug Administration (FDA).
ITM opened its U.S. headquarters in Princeton, New Jersey in April 2023. Upon opening its new offices, the company prepared for potential market registration of its targeted radiopharmaceutical pipeline product candidates and filed for obtaining the wholesale license. After an inspection from regulatory bodies that found no deficiencies, the wholesale license was issued to ITM on January 16, 2024.
“Obtaining the wholesale license is a crucial step in expanding our U.S. business as we prepare for the future launch of both our diagnostic and therapeutic radiopharmaceutical products in this important geography,” commented Steffen Schuster, CEO of ITM. “With this license and our U.S. team in place, we are on the right path to growing our capabilities in serving the healthcare community, our partners, and most importantly, patients on a global scale.”
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