Benuvia Operations Forms Strategic Partnership for Dronabinol API Supply with Major U.S. Pharmaceutical Firm
In a notable development for the pharmaceutical industry, Benuvia Operations, LLC, a prominent Contract Development and Manufacturing Organization (CDMO) based in the U.S., has recently entered into a multi-year supply agreement with a leading U.S. pharmaceutical company for its Active Pharmaceutical Ingredient (API), Dronabinol. This agreement, signed on May 13, 2025, marks a significant step in Benuvia's role in advancing product development for cannabinoid-based medications.
The contract allows the pharmaceutical company to reference Benuvia's U.S. Drug Master File (DMF) for Dronabinol while making regulatory submissions to the U.S. Food and Drug Administration (FDA). This collaboration is designed to enhance the development of a cannabinoid-based drug, ultimately aiming to improve patient access to safe and effective treatment options powered by quality ingredients.
Terry Novak, CEO of Benuvia, emphasized the importance of this partnership, stating, "This collaboration highlights Benuvia's standing as a reliable provider of pharmaceutical-grade cannabinoid APIs. As the demand for quality U.S.-produced cannabinoid ingredients continues to grow, our commitment is to support our partners' development efforts with scientific excellence and reliability in operations."
Benuvia has established itself as an industry leader through its high-quality manufacturing standards, regulatory adherence, and consistent supply reliability. The company engages with pharmaceutical clients throughout every stage of product development, from early-stage ideas to commercial production. Its range of APis includes not only Dronabinol but also other controlled substances ranging from cannabinoid products to psychedelics.
Operating from a fully integrated manufacturing facility in Round Rock, Texas, Benuvia's site is both FDA-audited and DEA-registered, allowing the company to handle a wide array of controlled substances safely. This facility spans 83,000 square feet, offering a secure and effective environment for manufacturing procedures that comply with stringent pharmaceutical regulations.
The FDA auditing process ensures that Benuvia meets the highest quality standards for manufacturing while also providing extensive services. These services encompass drug substance manufacturing, analytical development, and regulatory support for the handling of DEA-listed controlled substances. Benuvia's commitment to comprehensive solutions for clients through the entire drug development lifecycle underscores its authority in the industry.
In addition to this agreement, Benuvia has been actively engaging in various projects, including recent initiatives to support the research and development of next-generation cannabinoid products. The company's efforts in this space are indicative of a broader trend within the pharmaceutical sector to embrace cannabinoid therapeutics. As the scientific understanding of cannabinoids continues to evolve, so does the market's appetite for high-quality, reliable production sources for these complex substances.
Moving forward, Benuvia plans to leverage its established expertise to expand its offerings while continuing to remain at the forefront of innovation in the pharmaceutical industry. By focusing on quality, compliance, and operational reliability, Benuvia aims to establish long-term partnerships that not only enhance its market position but also significantly contribute to patient care and access to advanced therapeutic options. In conclusion, the partnership between Benuvia and the U.S. pharmaceutical company is not just a business agreement; it represents a pivotal moment in the journey toward effective cannabinoid-based medication solutions, with the ultimate goal of enhancing access to safe treatments for patients in need.
The contract allows the pharmaceutical company to reference Benuvia's U.S. Drug Master File (DMF) for Dronabinol while making regulatory submissions to the U.S. Food and Drug Administration (FDA). This collaboration is designed to enhance the development of a cannabinoid-based drug, ultimately aiming to improve patient access to safe and effective treatment options powered by quality ingredients.
Terry Novak, CEO of Benuvia, emphasized the importance of this partnership, stating, "This collaboration highlights Benuvia's standing as a reliable provider of pharmaceutical-grade cannabinoid APIs. As the demand for quality U.S.-produced cannabinoid ingredients continues to grow, our commitment is to support our partners' development efforts with scientific excellence and reliability in operations."
Benuvia has established itself as an industry leader through its high-quality manufacturing standards, regulatory adherence, and consistent supply reliability. The company engages with pharmaceutical clients throughout every stage of product development, from early-stage ideas to commercial production. Its range of APis includes not only Dronabinol but also other controlled substances ranging from cannabinoid products to psychedelics.
Operating from a fully integrated manufacturing facility in Round Rock, Texas, Benuvia's site is both FDA-audited and DEA-registered, allowing the company to handle a wide array of controlled substances safely. This facility spans 83,000 square feet, offering a secure and effective environment for manufacturing procedures that comply with stringent pharmaceutical regulations.
The FDA auditing process ensures that Benuvia meets the highest quality standards for manufacturing while also providing extensive services. These services encompass drug substance manufacturing, analytical development, and regulatory support for the handling of DEA-listed controlled substances. Benuvia's commitment to comprehensive solutions for clients through the entire drug development lifecycle underscores its authority in the industry.
In addition to this agreement, Benuvia has been actively engaging in various projects, including recent initiatives to support the research and development of next-generation cannabinoid products. The company's efforts in this space are indicative of a broader trend within the pharmaceutical sector to embrace cannabinoid therapeutics. As the scientific understanding of cannabinoids continues to evolve, so does the market's appetite for high-quality, reliable production sources for these complex substances.
Moving forward, Benuvia plans to leverage its established expertise to expand its offerings while continuing to remain at the forefront of innovation in the pharmaceutical industry. By focusing on quality, compliance, and operational reliability, Benuvia aims to establish long-term partnerships that not only enhance its market position but also significantly contribute to patient care and access to advanced therapeutic options. In conclusion, the partnership between Benuvia and the U.S. pharmaceutical company is not just a business agreement; it represents a pivotal moment in the journey toward effective cannabinoid-based medication solutions, with the ultimate goal of enhancing access to safe treatments for patients in need.
Topics Health）
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