Berkshire Sterile Obtains First FDA Commercial Drug Approval | News

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Lee, MA, March 22, 2022 (GLOBE NEWSWIRE) — On March 1, 2022, a longtime customer of Berkshire Sterile Manufacturing (BSM) announced FDA approval of its Abbreviated New Drug Application (ANDA) for its generic apomorphine hydrochloride cartridges. The drug is the first product manufactured by BSM to receive FDA approval for commercial human use. “We are thrilled to announce this milestone,” said CEO and Co-Founder Dr. Shawn Kinney. “We’ve worked with this company since the first year we started manufacturing drugs, and it was a pleasure to help them with their application and ultimately get FDA approval.” Berkshire Sterile was founded in July 2014 and began filling on flexible isolator-based filling lines in the spring of 2016. Since then it has grown to over 200 employees, working with over 170 different companies with scale programs clinical. The approval of this ANDA program should 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 range of analytical services and micro-offerings. BSM grew rapidly 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 batches with also commercial freeze-drying capacities. “This customer’s approval is an important milestone in our mandate and drive for excellence in manufacturing sterile products,” said CTO and co-founder Dr. Andrea Wagner. BSM’s mission is to provide its customers with a product that has the highest level of sterility and quality assurance achievable in sterile filling, while also striving to maintain flexibility in container selection. “We believe quality is the result of intelligent effort,” Andrea said. “Every day we strive to be a little smarter about how we do things. We are continually developing training and moving towards new, innovative ways to achieve our own goals and those of our customers.”

About Berkshire Sterile Manufacturing Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer specializing in the sterile filling of syringes, vials and cartridges for the biotechnology and pharmaceutical industries. BSM also offers terminal vapor sterilization of syringes, specialized filling, lyophilization of vials, liquid/liquid and liquid/lyo dual chamber, all in one isolator. Lyophilization development, formulation development, and method development are also offered. Please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact us at [email protected] for more information.

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Filling of cartridges on BSM’s semi-automated isolator line

Andrea Wagner Berkshire Sterile Products Manufacturing 413-243-0330 [email protected]

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