Controlled Substances
Drug Engine Pharma understands the risks involved in developing APIs for controlled substances. Therefore, it only partners with vendors with the proper infrastructure, processes, and expertise to handle controlled substances while complying with strict regulatory requirements.

Through our vendors, we can handle the five classifications of controlled substances:
Schedule I: Drugs without current accepted medical use and a high potential for abuse.
Schedule II: Drugs that exhibit a high potential for abuse and result in severe psychological or physical dependence.
Schedule III: Drugs with moderate to low potential for physical and psychological reliance.
Schedule IV: Drugs with low potential for abuse and risk of dependence
Schedule V: Drugs with lower potential for abuse and contain a limited amount of narcotics
Working with our preferred vendors comes with suitable cGMP facilities, equipment, and technology and guarantees the utmost security. Only authorized personnel will have special access to all relevant facilities and data. Employees undergo background checks while every cGMP suite and entry point are equipped with monitoring devices.
Another critical factor we consider is meeting the regulatory guidelines in handling controlled substances.
Efficient Software Programs
Our vendors use a comprehensive Compliance Management System and Quality Risk Management solution to ensure the implementation of processes and to document compliance records.
Positive Relationships with Governing Bodies
Aside from being registered and licensed to manufacture controlled substances, our vendors have established a friendly and trustworthy relationship with governing bodies such as the FDA and DEA. They keep updated on any changes in guidelines and follow best practices.
High-Quality Raw Materials
It’s crucial to source high-quality raw materials so our vendors ensure a good supply flow while meeting regulatory requirements.
Comprehensive Safety Controls
Our vendors implement comprehensive environmental, laboratory, security, and material controls for safety and efficacy when handling your controlled substance. Every employee understands and goes through training to adhere to cGMP protocols to properly manufacture, handle, and store the substances.
Working with DEP and our team of vendors helps you reduce costs, navigate stringent regulatory controls, and maintain your controlled substance’s quality, safety, purity, and identity. As a result, you could meet the increasing demand for new molecules offering medical value in different areas, including pain management and psychiatric disorders.
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