Medivant Healthcare

A boutique, FDA approved cGMP (Current Good Manufacturing Practice) manufacturer

Based in Chandler, Arizona, Medivant Healthcare counts on extensive lineage in the larger pharmaceutical manufacturing world. Managed by ownership that dates three generations in pharmaceuticals, Medivant is the newest, sterile Single Dose liquid injectable facility in the US, consistently manufacturing medications on the FDA’s drug shortage list.

As a boutique, FDA approved cGMP (Current Good Manufacturing Practice) manufacturer, Medivant is guided by automation that naturally leads to greater output. Generic medications are in high use at hospitals and very few US manufacturers produce them at a volume that justifies the upfront investments.

Medivant serves hospitals, hospital groups, surgical centers, doctors’ offices and emergency centers. It is a business-to-business model with no direct to consumer sales. Over the long-term Medivant seeks to be a leader in this sector, hoping to revive pharmaceutical manufacturing interest in the United States.

 

Our Facility

The FDA employs stringent guidelines via their cGMP regulations. The Medivant Healthcare facility is the most current, full-scale facility of its kind, fully compliant with cGMP in the United States. Fully automated with a novel, single line-manufacturing set-up (featuring aqueous sterile injectable products), the Chandler facility was designed by leading architects and engineers working in the larger healthcare sphere.

The facility’s in-house lab is a state-of-the-art sterility & chemistry lab, strategically equipped to handle Multi-Stage Sterility Checks as well as In-House Bud Studies. Medivant is currently only occupying 1/3rd of its space with plans to roll out over the remaining 2/3rds over the subsequent two to three years. Growth will be swift and promising.

Quality and Compliance

As a cGMP manufacturer, safety and quality are paramount and guide all decisions across the organization. Automation has led to little to no human error, and specialist QA teams (in-house) work diligently to ensure compliance is met no matter how minute or seemingly insignificant the detail. Medivant takes great care to out-source very little of its quality and system control staff, and relies as such on an in-house, trained group of pharmaceutical professionals to ensure strict compliance with cGMP standards.Production and Process Capable or producing 80,000 vials of 1-10 ML Single Dose Liquid Injectables per day, our facility averages 40,000 vials per shift with a staff of roughly 20 fully-trained professionals. Rollout over the coming years is expected to reach nearly half of the United States and our current count of 16 molecules in production will reach 25 plus by 2021.

Medivant Team

Viraj Gandhi
Owner & Director of Medivant Healthare

Viraj Gandhi is the Owner and Director of Medivant Healthcare (Tailstorm Health, Inc.), the newest, sterile single dose liquid injectable facility in the US, dedicated to manufacturing medications on the FDA’s drug shortage list.

Based in Phoenix, Arizona, Medivant Healthcare’s fully automated cGMP sterile injectable pharmaceutical manufacturing facility will begin commercial production in early May 2020. Medivant’s initial products will include liquid injectables that are in dire need in the ICU for Covid19 patients.

Gandhi’s family has a long history of success and experience in the pharmaceutical industry. The family began their efforts in pharmaceuticals in 1960 where they became the first Indian Distributors for Pfizer. The family’s work continued throughout the decades and includes milestones such as setting up the first few pharmaceutical manufacturing facilities in India for oral solids, starting the first sterile injectable manufacturing facility, launching APR Manufacturing, and setting up India’s first pharmacy chain. In 2015, the family acquired their first US business, a speciality pharmacy in Phoenix, Arizona, which they sold to CVS Pharmacy in 2018.

Viraj Gandhi became acting Director of Medivant Healthcare in 2015. Over the last five years and under Gandhi’s direction, the group acquired a pharmacy in the Phoenix area, which now caters to long term care and assisted living facilities. Additionally, Medivant launched a Specialty Pharmacy Division, which perpetuated exponential growth by 25 times, before selling the business to CVS in 2018. Today, the company’s sole focus is launching the greenfield cGMP pharmaceutical manufacturing facility in Phoenix, Arizona.

Additionally, for the last seven years, Gandhi has served as Director at Prefunc, an herbal lifestyle management drink that helps the body deal with the effects of a night out. Prefunc is made in the USA at a cGMP US FDA approved facility with US sourced ingredients. The company launched the product in Miami and are now expanding throughout the southern and western parts of the United States.

Prior to launching Medivant, Gandhi directed business efforts at Gentech Labs Ltd, a group that helps mobilize businesses with a website called Jemobi.

Over the last two decades, Gandhi’s leadership roles have spanned across a variety of global healthcare companies, including ICare Opticals, Medicine Shoppe India, Gentech Laboratories, Dolphin Laboratiroes, and AVP Sales.

Viraj Gandhi earned his Bachelor of Science in Business Administration in Finance and Economics from Babson College.


Anujj Patodia
Director, Medivant Healthcare

Anujj Patodia is the Director at Medivant Healthcare where his role includes advising the board on project management and execution.

Patodia has extensive experience in manufacturing with an emphasis on industrial engineering and work load study. He has created and executed multiple marketing strategies in various industries ranging from fashion to commodities and real estate.

Having set up multiple green field projects, Patodia holds a deep understanding of project planning, management and execution. Recruitment has always been a critical role for Patodia. He prides himself on getting the right people in the right place and enjoys being heavily involved in the recruitment process across various levels.

In addition to his role at Medivant Healthcare, Patodia is the Managing Director at Prime Urban Development India, Ltd., where he has served for over 17 years.

In 2002, Anujj Patodia joined Prime Urban Development where he served as Executive Director, and lead the management team in a strategic role. In 2005, he lead the company to the Real Estate business to utilize its vast land bank. This included creating strategic partnerships
with construction companies, as well as financing. Patodia started from the ground up by creating a project management team for the construction, while also creating the company’s marketing strategies. He worked with all vendors to ensure all project timelines were maintained as per their project plan. Extensively, Patodia used industrial engineering to determine the workload of the people and followed that with regular time studies to ensure timely execution.

On the marketing side, he regularly visited prospective customers along with their sales team to gauge the response of marketing strategies, constantly improving with learning. Over the years, he started handing over the operations to the team and moving back to a management and strategy role with emphasis on finance and project analysis.

Additionally, Patodia has been instrumental in the development of the biggest luggage brand in India, Safari Industries, where he continues to serve as Director on the Board. Safari is in the business of manufacturing and trading of luggage and luggage accessories and is listed on the Indian Stock Exchanges.


Andrew Stasiak
Director of Quality, Medivant Healthcare

Andrew Stasiak is a Certified Quality Auditor who currently serves as Director of Quality at Medivant Healthcare (Tailstorm Health, Inc.), the newest, sterile single dose liquid injectable facility in the US, dedicated to manufacturing medications on the FDA’s drug shortage list. He specializes in pharmaceutical audits and is considered a subject matter expert in the fields of Computer Systems Validation, as well as process validation.

Based in Phoenix, Arizona, Medivant Healthcare’s fully automated cGMP sterile injectable pharmaceutical manufacturing facility will begin commercial production in early May 2020. Medivant’s initial products will include liquid injectables that are in dire need in the ICU for Covid19 patients.

Hired during the design and development of the aseptic parenteral manufacturing facility, Stasiak has worked to bring the organization from an empty building through systems development and into FDA compliance for the manufacture of sterile drug products. Stasiak was directly involved in the hiring of all staff, all validation activities, development of all procedures, training employees, and all other activities to bring the pharmaceutical company into production.

He currently oversees all Quality Assurance and Quality Control activities as well as indirectly supervises manufacturing activities. Stasiak authored approximately 80% of all Standard Operating Procedures and oversaw the design, commissioning, and validation of all equipment and procedures. He is the Point of Contact for regulatory interactions for the FDA, DEA, and Arizona Board of Pharmacy. Additionally, Stasiak manages the final release of drug product for human use.

Having earned his Masters of Science Degree from San Diego State University, Stasiak is a demonstrated leader in FDA compliant quality operations who has overseen a variety of global pharmaceutical and medical device manufacturing, testing, and clinical programs. Prior to Medivant Healthcare, Stasiak supervised quality control for a wide variety of organizations including Hollister-Stier Laboratories, Insys Therapeutics, and W.L Gore and Associates.

Stasiak has developed, implemented, and expanded quality systems for organizations large and small and has extensive experience with global regulatory compliance. He is the subject matter expert in the areas of sterile pharmaceutical manufacturing, process validation, computer system validation, and laboratory equipment validation and has successfully led organizations through many regulatory inspections and has performed more than 100 cGMP, GLP, and GCP audits in 20 countries.