Mikart and Benuvia Partner to Deliver Controlled Substance Development and Finished Drug Product Manufacturing Solutions

Mikart and Benuvia Operations announced a strategic co-marketing partnership to provide fully integrated, end-to-end solutions spanning drug substance (API) development through finished drug product manufacturing. By aligning their expertise, the companies aim to deliver a seamless experience for pharmaceutical and biotechnology partners seeking efficiency, quality, and regulatory excellence. The partnership is specifically designed to enhance customer value by streamlining development timelines, improving cross-functional coordination, and expanding access to specialized controlled-substance expertise within a single, unified framework.  

Under the agreement, both organizations will jointly promote their services on a global scale and actively collaborate on business development initiatives. These efforts will include shared customer engagements, coordinated presentations, participation in major industry events, and targeted outreach to prospective clients. By leveraging each company's established reputation and network, the partnership is positioned to broaden market reach and accelerate growth opportunities. 

"This partnership strengthens our ability to support customers across the full product lifecycle," said Michael Kallelis, CEO of Mikart. "By aligning with Benuvia, we are adding critical API capabilities and deep expertise in controlled substances, enabling a more seamless, efficient, and comprehensive offering for our clients." 

Terry Novak, CEO of Benuvia, added, "Mikart's strength in formulation and finished dose manufacturing complements our capabilities in small molecule API development and controlled substance manufacturing. Together, we offer customers a seamless, highly differentiated, U.S.-based CDMO solution that prioritizes quality, compliance, and speed to market." 

The partnership will initially focus on key areas including controlled substances, cannabinoids, and emerging therapeutic categories, where the combined technical, regulatory, and manufacturing expertise of both organizations provides significant advantages. Additionally, Mikart and Benuvia plan to collaborate on joint marketing initiatives, industry events, and customer engagement strategies to further expand awareness, strengthen industry relationships, and drive new business opportunities. 


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