Apiject Seeks FDA Approval for Next-Gen Prefilled Single-Dose Injection Device

Apiject Seeks FDA Clearance for Next-Gen Prefilled Single-Dose Injection Device

Apiject Systems, Corp. announced that it has submitted a New Drug Application (NDA) to the FDA seeking regulatory approval for the worlds first injectable medicine delivered via Apijects single-dose, single-use prefilled plastic syringe. Central to the NDA proposal for the drug Glycopyrrolate in the Apiject injection equipment is a drug supply development platform that incorporates two proven medical technologies: Blow-Fill-Seal (BFS) liquid packing technology and precision injection molding of pen-style needle centers. This grouping enables the development of a new category of prefilled drug delivery strategies that are more scalable and cost-effective than traditional glass vials and prefilled syringes. The major advantage of BFS is that it is an incessant manufacturing procedure that functions at high speed and depends on a single raw resource that is obtainable domestically.

Jay Walker, Co-Founder, Executive Chairman, and CEO of Apiject, said,

"This proposal is a thrilling and important step forward for Apiject. We have spent the last 5 years preparing BFS to play a central role in the upcoming period of drug delivery, as it fulfills the requirements of the new trials in healthcare realism. Our work has involved a comprehensive strategy and growth in drug containers and devices, as well as improvements to the engineering process, the creation of new devices, and extensive end-to-end testing. The worldwide demand for medical inoculations is expected to continue developing at a double-digit pace. We require new domestic capacity, more flexibility, lower charges, and we require new thinking."

Mr. Walker further added:

"Basic manufacturing, compressed supply chains, flexible construction that can scale rapidly, decreased foreign dependencies, lower carbon output, and more reasonable prefilled resolutions are what the U.S. and the world require right now for commercial usage, public health movements, and emergency response. And thats precisely the kind of invention we are emphasizing on at Apiject."

BFS is extremely flexible in terms of container patterns and sizes, accommodating a wide variety of medical uses, including nasal drops, eye drops, ear drops, wound care, and sterile water. And now it will be utilized for injections, inhalants, and infusions. In 2004, the FDA officially documented BFS as a progressive aseptic procedure. In its supervision document, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, the FDA defined BFS as an "automated procedure by which containers are molded, filled, and sealed in a constant operation."