Company intelligence / Profile preview
Iso-Tex Diagnostics
Alvin, Texas, United Statesisotexdiagnostics.com ↗
- Ownership
- Private
- Employees
- ~8
- Development stage
- Other
01
Overview
Iso-Tex Diagnostics specialized in the development and manufacturing of sterile, non-pyrogenic radiopharmaceuticals for both diagnostic and therapeutic use. Its portfolio included FDA-approved products such as Glofil® (Iothalamate Sodium I‑125) for measuring glomerular filtration rate, with a focus on specialty formulations for terminal cancer patients. The company operated under cGMP/GLP standards but received an FDA warning letter in 2023 regarding CGMP violations related to aseptic processing controls. In March 2024, Daxor Corporation acquired exclusive worldwide rights to manufacture Volumex®, Megatope®, and Glofil® from Iso-Tex Diagnostics.
- Therapeutic areas
- NephrologyOncology
- Modalities
- RadiopharmaceuticalProtein drugSmall molecule
- Industry
- Biotech
02
Drug pipeline
1 asset03
Partnerships
Daxor Corporation [acquirer]
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