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Mark Cuban Cost Plus drug Company partners with Fedegari on disruptive drug manufacturing project

 The new US flexible sterile fill-finish facility will benefit from Fedegari cost-effective integration of washing and sterilization processes in one single unit to provide extremely competitive versions of high-cost generic drugs in US.

Fedegari has been selected to partner with Mark Cuban Cost Plus Drug Company (MCCPDC) on supplying washing and sterilization equipment to its new facility in Dallas, Texas. The 22,000-square-foot 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 sterilization 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

Smaller Footprint Maximizes Available Space

“Fedegari unique product offerings allow us to maximize the space available. This enables us to be more efficient and effective in our pharma manufacturing”, said Alex Oshmyansky, MD, PhD, CEO of MCCPDC. “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”, adds Oshmyansky.

Efficient Small Batch Production

MCCPDC facility’s innovative design – with flexible and unconventional process equipment such as Fedegari washer-sterilizers – 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”, explains Oshmyansky.

Disruption Through Multi-Purpose Equipment

“In the selection process, we looked for highly innovative solutions in terms of cost-effectiveness and equipment flexibility. We chose Fedegari’s washer-sterilizer as it combines two processes in one machine. This multipurpose equipment reduces our operating costs while combining the high-performance of a steam sterilizer 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,” completes Oshmyansky.

 

Cost-Effective Production of Life-Enhancing Drugs

“We enthusiastically support Mark Cuban Cost Plus Drug Company on its vision to save more lives through cost-effective manufacturing of life-enhancing drugs,” says Fedegari President, Giuseppe Fedegari. “Finding partners like MCCPDC, who are willing to find unconventional ways of producing sterile drugs, is why we’re so passionate about our designs and equipment solutions. We’re proud to provide innovative and flexible technology that aids MCCPDC disruptive manufacturing approach. Dramatically reducing the production costs of small drug batches inspires us to keep innovating. Together we can create a better future for all.”

Patient care, pharmacy operations and drug shortages remain ongoing public health concerns in the U.S. Prior to COVID-19, hospitals were already experiencing shortages of key drugs. Unprecedented demand — due to the number of critically-ill COVID-19 patients — worsened drug shortages, reported by the AMA Council on Science and Public Health in November 2020.

“We are proud to provide innovative and flexible technology. Dramatically reducing the cost of producing small batches of drugs, in the US is very important. Together we can create a better future for everyone,” adds Alfonso Fasano, ASM.

Watch the Customer Success Project video!

Fedegari’s Hybrid Washer-Sterilizer

The Fedegari FOWS washer-sterilizer is a hybrid solution suitable for washing, decontaminating, sterilizing, 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.

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