Huayi Isotopes Achieves FDA DMF Acceptance for DOTATATE ACETATE

Huayi Isotopes, a subsidiary of Huayi Technology Co., Ltd., has received a Drug Master File (DMF) acceptance letter from the U.S. Food and Drug Administration (FDA) for its DOTATATE ACETATE (DMF No. 041558), a peptide-based precursor for radiopharmaceuticals. This milestone underscores Huayi’s commitment to global compliance in the radiopharmaceutical sector and strengthens its foundation for international market expansion.

About DOTATATE ACETATE

DOTATATE ACETATE is a critical component in the synthesis of radiopharmaceuticals for neuroendocrine tumors (NETs). Featuring a high-affinity targeting peptide moiety, it enables precise labeling with isotopes such as ⁶⁴Cu, ⁶⁸Ga, and ¹⁷⁷Lu, facilitating molecular imaging diagnostics and targeted radiotherapy. The product is characterized by exceptional purity and batch-to-batch consistency, making it ideal for automated synthesis modules and a cornerstone in radiopharmaceutical manufacturing.

Enhanced Services: One-Stop Support for Radiopharmaceutical APIs
Huayi Isotopes now offers comprehensive solutions for radiopharmaceutical development and production:

● Custom Radiopharmaceutical Precursors: Development of peptides, chelators, and isotope labeling precursors.

● Regulatory Support: Streamlined registration and consultation services to accelerate global market entry.

● Analytical Method Development & Validation: Tailored protocols (HPLC, LC-MS, GC) to support IND, NDA, and other regulatory filings.

● GMP-Compliant Manufacturing: Fully automated fill-finish and lyophilization capabilities adhering to global GMP standards.

About Huayi Isotopes
As a strategic division of Huayi Technology, Huayi Isotopes specializes in the R&D and production of nuclear medicine precursors and consumables, delivering end-to-end radiopharmaceutical solutions. Equipped with multiple GMP-certified production lines and internationally recognized expertise, the company has solidified its position as a leader in precision radiopharmaceutical development. The FDA acceptance of its DOTATATE ACETATE DMF further validates Huayi Isotopes’s technical excellence and compliance readiness in the global arena.