The 22,000 sqft sterile fill-finish site will manufacture and provide low-cost versions of high-cost generic drugs using Fedegari's innovative design which combines the washing and sterilisation process into one unit
Fedegari has been selected to partner with Mark Cuban Cost Plus Drug Company (MCCPDC) on supplying washing and sterilisation equipment to its new facility in Dallas, Texas.
The 22,000 sqft sterile fill-finish site will manufacture and provide low-cost versions of high-cost generic drugs using Fedegari's innovative design which combines the washing and sterilisation process into one unit.
Planned for completion in 2022, the plant will be registered with the US FDA to rapidly respond to drug shortages. The Dallas facility is designed to manufacture competitive sterile medicines.
Alex Oshmyansky, MD, PhD, CEO of MCCPDC, said: "We aim to save and improve lives by providing products that patients would otherwise be unable to get, or which would come at a prohibitive cost."
The plant will be registered with the US FDA to rapidly respond to drug shortages
MCCPDC facility's innovative design - with flexible and unconventional process equipment such as Fedegari washer-sterilisers - will enable small-batch manufacturing at a lower cost. As a result, drugs listed by the FDA as short in supply can be made available more quickly. Additionally, the new plant will produce "orphan drugs", medicines intended for the treatment of rare diseases affecting the poorest part of the population.
Oshmyansky, a physician and founder of the company, conceived this disruptive manufacturing idea after seeing patients struggle with the high cost of drugs.
The US pharmaceutical industry is facing numerous challenges, many of which are further complicated by the pandemic and interrupted supply chains. MCCPDC facility will tackle industry disruptions in an innovative way. "We are looking to disintermediate supply chains in the US and provide patients and providers our products directly while bypassing intermediaries. The new production site will enable us to create products for small communities of patients that would otherwise not be able to obtain them," explained Oshmyansky.
"In the selection process, we looked for highly innovative solutions in terms of cost-effectiveness and equipment flexibility. We chose Fedegari's washer-steriliser as it combines two processes in one machine. This multipurpose equipment reduces our operating costs while combining the high-performance of a steam steriliser into a jet washer. When compared with the traditional solutions, we are able to minimize the equipment's footprint and reduce processing time. Fedegari is a proactive and efficient partner, especially with regard to our business activities and our work with regulators," said Oshmyansky.
The Fedegari FOWS washer-sterilizer is a hybrid solution suitable for washing, decontaminating, sterilising, and drying various types of loads, unlike traditional machine solutions.
On the washing cycle, the FOWS washer sterilizer harnesses the emollient effect of steam on greasy and sticky dirt such as ointments, creams, gels, etc. Fedegari's design reduces the consumption of detergents, water and energy delivering a superior eco-friendly solution. For drying, the unit's vacuum reduces drying cycle duration and lowers operating costs.