A long-term client of Berkshire Sterile Manufacturing (BSM) announced the FDA approval of their Abbreviated New Drug Application (ANDA) for their generic apomorphine hydrochloride cartridges. The drug marks the first product produced at BSM to receive FDA approval for commercial human use.
“We are excited to announce this milestone event,” stated CEO and cofounder, Dr. Shawn Kinney. “We have worked with this company since the first year we began manufacturing drug product, and it has been a pleasure to help them with their application and ultimately achieve an FDA approval.”
Berkshire Sterile was founded in July of 2014 and began filling on isolator-based, flexible filling lines in the spring of 2016. They have since grown to over 200 employees, working with over 170 different companies with clinical-scale programs. The approval of this ANDA program is expected to be the first of many to follow.
BSM performs formulation, formulation development, sterile filling of vials, syringes, and cartridges, lyophilization, analytical development, and validation as well as a full-service array of analytical and micro-offerings. BSM has expanded quickly to meet demand and invested in innovative, isolator-based filling lines. They are currently adding a third line to increase their capacity to 90,000 unit lots with commercial capabilities for lyophilization as well.
“This client’s approval is a significant step forward in our tenure and our drive to excellence in sterile manufacturing,” stated CTO and cofounder, Dr. Andrea Wagner.
BSM’s mission is to provide its clients with a product that has the highest level of sterility assurance and quality achievable in sterile filling, while also striving to maintain flexibility in container choice.
“We believe quality is a result of intelligent effort,” stated Andrea. “Every day, we strive to get a bit smarter about how we do things. We are continually expanding training and moving towards new and innovative means to reach our own and our clients’ goals.”
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