As the pharmaceutical industry evolves, the exploration of alternative and plant-derived therapies has moved from the fringe to the forefront of innovation. Cannabinoids and psilocybin—once primarily associated with natural wellness communities—are now the focus of serious research and emerging regulatory pathways aimed at treating a wide range of conditions, including chronic pain, epilepsy, anxiety, depression, and PTSD.
At Mikart, we recognize the potential of these therapies and are well-positioned to support companies seeking to bring them to market.
Who’s Leading the Way in Cannabinoid and Psilocybin Development?
Around the globe, research institutions, biotech startups, and established pharmaceutical companies are investing heavily in cannabinoid and psilocybin therapies. Organizations across the U.S., Canada, Europe, and Australia are leading clinical trials and regulatory submissions, focusing on the development of standardized, reproducible, and pharmaceutically compliant products.
As regulations begin to shift—particularly in the U.S., where the FDA has already approved cannabinoid-based therapies like Epidiolex®—the demand for experienced contract development and manufacturing organizations (CDMOs) is growing. Psilocybin is also gaining traction, with the FDA granting “Breakthrough Therapy” designation to several psilocybin-assisted treatments currently in clinical trials.
How Mikart Can Support Your Cannabinoid and Psilocybin Programs
As a trusted CDMO, Mikart provides the infrastructure and expertise needed to guide complex products from concept to commercialization, including cannabinoid- and psilocybin-based therapies. We are licensed by the Drug Enforcement Administration (DEA) to handle Schedule I through V substances and have been manufacturing and packaging controlled drug products for over 50 years. Our team is experienced in navigating the unique regulatory, formulation, and manufacturing challenges these compounds present.
Our capabilities include:
- Controlled Substance Handling: Mikart is licensed to handle Schedule I–V controlled substances, offering secure and compliant manufacturing and storage.
- Formulation Expertise: Whether your compound is intended for oral solid dose, liquid, or alternative delivery systems, Mikart’s scientists are prepared to address bioavailability, stability, and dosing challenges.
- Clinical and Commercial Manufacturing: We offer flexible batch sizes to support early-phase clinical trials through full commercial scale-up.
- Regulatory Support: Our regulatory affairs team ensures that your cannabinoid or psilocybin product aligns with FDA, DEA, and international guidelines—facilitating a smoother path to approval.
Looking Ahead
As the landscape for cannabinoid and psilocybin therapies continues to evolve, the right CDMO partner will make all the difference in navigating compliance, scalability, and speed to market. Mikart stands ready to be that partner—offering trusted experience, state-of-the-art facilities, and a collaborative approach.
If you’re developing cannabinoid or psilocybin-based therapies and need a manufacturing partner, contact us to learn how Mikart can help turn your vision into reality.
