ten23 health celebrates first and only FDA-approved subcutaneous loop diuretic

ten23 health, a global contract development and manufacturing organization (CDMO), celebrates the success of scPharmaceuticals, a pharmaceutical company headquartered in Burlington, MA USA, focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies. ten23 was pivotal in supporting scPharmaceuticals’ for the U.S. Food and Drug Administration’s (FDA) approval of FUROSCIX (furosemide injection) with the implementation and fill/finish of the large (10 mL) volume polymer cartridges of the delivery device. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic that can be self-administered at-home.

“We are very happy to have supported scPharmaceuticals in the development of FUROSCIX which they expect to commercially launch in Q1 2023. With our unique capability and expertise in filling complex sterile drug products such as the 10 mL polymer pre-filled cartridge used in the On-Body Infusor for FUROSCIX, we provide comprehensive solutions to our partners,” says Prof. Dr. Hanns-Christian Mahler, CEO of ten23 health.

FUROSCIX enables subcutaneous administration at home by the patient or a caregiver with the use of the On-Body Infusor for FUROSCIX. The pre-filled cartridge is inserted into the pre-programmed single-use On-Body Infusor for FUROSCIX, attached to the abdomen and then activated with the press of a button to deliver the dose over five hours. The FUROSCIX infusor will deliver only an 80-mg dose.

ten23 health's expertise and focus is on patients, improved formulations and delivery of parenteral drugs.  Our scientific, regulatory and applied industrial knowhow in combination with our unique technical development and sterile manufacturing capabilities, enable customers to enter clinical testing and commercialization with high-precision and low-headspace pre-filled syringes or cartridge-based systems alike, using most recent delivery technologies, in close collaboration with device manufacturers and primary packaging suppliers.