CIRC Subsidiary CNGT Secures U.S. FDA DMF Activation for Lu-177 API

Bulletin Express09-22

CIRC announced that its wholly owned subsidiary, Chengdu Gaotong Isotope (CNGT), has obtained U.S. Food and Drug Administration clearance for its Lu-177 active pharmaceutical ingredient Drug Master File (DMF). The FDA confirmation letter activates the DMF number, formally recognizing the Lu-177 API for regulatory citation in the United States.

The DMF activation allows downstream radiopharmaceutical manufacturers to reference CNGT’s Lu-177 API directly in their own FDA submissions, eliminating the need to provide separate API documentation. This change is expected to streamline the application process, shorten review timelines, and reduce filing costs for partners developing Lu-177-based therapeutics.

Management noted that the FDA clearance marks a pivotal milestone in CNGT’s international expansion strategy for nuclear-medicine raw materials. The approval is anticipated to strengthen confidence among current and prospective clients, support ongoing cooperation negotiations, and accelerate broader commercialization efforts.

The Board of CIRC released the information on 22 September 2026. No financial figures were disclosed in the announcement.

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