Veranova has invested over 50 years building an extensive range of controlled substances, including opioids, stimulants, and cannabinoids. Backed by unparalleled experience, global GMP capabilities, and regulatory excellence, our team has the expertise to manage the sustainable, secure supply and manufacturing of these APIs with confidence.
Explore our portfolio of controlled substances
Many of the most promising therapeutics in development utilize controlled substances, spanning oncology, pain management, addiction treatment, and CNS therapies. But the complexity and stringent security measures required to handle controlled substances mean that working with the right CDMO partner is vital.
Originating from Macfarlan Smith Ltd, a globally recognized leader in opiate alkaloids, Veranova has unparalleled knowledge of controlled substance development and manufacturing. Leveraging robust infrastructure for handling, security, waste management, and audit readiness, our dedicated procedures and training help to ensure that APIs are developed and stored safely.
Our highly skilled professionals support our portfolio growth and help expedite product entry to market. Through close, collaborative partnerships, Veranova supports alignment between clients and regulatory agencies.
Learn more about our approach to quality and regulatory affairs
In recent years, there has been a large increase in patient interest for using cannabinoids to treat a range of conditions. As a result, countries around the world are beginning to relax regulations for cannabis use in medical situations, leading to fewer restrictions for researchers looking to investigate its potential applications. However, for pharmaceutical developers, the lack of standardized protocols between countries makes cannabinoid-based drug development challenging to manage.
Veranova’s involvement with pharmaceutical cannabinoids began 15 years ago when we supported the development of a generic substitute for Marinol. To support the launch of the generic, we invested tens of millions of dollars in large-scale supercritical fluid chromatography and other equipment at our West Deptford, N.J., plant, to achieve the high purity needed to prevent THC from oxidizing readily.
To gain FDA approval, a product must meet high purity standards. Our team leveraged their advanced technical expertise to develop a validated process for cannabidiol synthesis (filed with a US DMF). We also created reference standards for our cannabinoids. These reference standards helped our customers understand the product and gave them the confidence to formulate with our APIs. In the future, we plan to expand our portfolio to include other synthetic cannabinoids.
In response to a greater demand for more patient-centric, complex and personalized treatments, scientists are beginning to explore the therapeutic applications of psychedelic substances, especially in the treatment of illnesses such as addiction, depression, anxiety and posttraumatic stress disorder (PTSD).
Figure 1: Psychedelic substances of therapeutic interest to the pharmaceutical industry.
However, there are several difficulties associated with the quality, potency, safety, and efficacy of psychedelic substances. Moreover, strict regulatory controls pose a challenge for research and development in this area. With most psychedelics classified as Schedule I substances in the US and similarly restricted in other countries, development and manufacturing activities require government licenses, inspections, and oversight.
As a global CDMO that manages complexity with confidence, Veranova is positioned to help its customers mitigate these project hurdles and ensure consistent product attributes in the development and manufacturing of psychedelic substances for medical applications. Drawing from our strong background in navigating regulatory frameworks, we can help support innovators mitigate setbacks and efficiently maintain compliance throughout.
Our world-class US and UK facilities are GMP compliant. Each site holds the proper licenses to handle controlled substances.
From clinical to commercial scale, we combine consistent supply with flexible capacity to help ensure we meet our customers’ needs at every stage of the drug approval process
Discover new ways to advance your science with Veranova.
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