Controlled Substance Manufacturing & Development
Pharmaceutical companies that are interested in outsourcing the development and manufacture of DEA controlled substances need a partner that is equipped to perform cGMP processes as well as several other levels of operational complexities.
Registered and Experienced to Develop and Manufacture Schedule II-V Controlled Substances
Pharmaceutical companies that are interested in outsourcing the development and manufacture of DEA controlled substances need a partner that is equipped to perform cGMP processes as well as several other levels of operational complexities. In addition, distribution of controlled substances in the United States will require a US-based partner familiar with US regulations in order to ensure compliance.
Cedarburg Hauser Pharmaceuticals is a US-based company that is registered to develop, manufacture and ship schedule II-V controlled substances in the United States. We possess the experience, processes and facilities required to help you with your project. If you have a controlled substance project that needs development and manufacturing we invite you to request a quote today.
Critical Qualifications we Possess for Working with Controlled Substances
- We have an excellent relationship with the DEA and have an outstanding inspection history
- We have a robust compliance system in place for handling schedule II-V controlled substances
- We have comprehensive controls in place for manufacturing, handling, storage, stability and distribution of controlled substances
- We have an established system for handling international sales / shipments (import / export permits, DEA form 236, etc.)
We have the processes and procedures to address the requirements for developing, handling, manufacturing and shipping controlled substances
Environmental Controls
- Environmental containment issues and worker exposure limits – development and production suites with dedicated HVAC systems with single air pass and controls and cascading pressuring differentials between the labs and hallways to prevent cross-contamination
Laboratory Controls
- Equipment cleaning validations at extremely low levels
- Laboratory handling and control
- Special laboratory equipment must be used, properly isolated and cleaned
- Keycard security system
Material Handling Controls
- Inventory management, control and disposal
- Special handling requirements – receiving, transferring, packaging and shipping
Documentation
- Special documentation completed, submitted and filed surrounding the development, manufacturing, receiving and shipping of controlled substances.
Training
- All laboratory staff are thoroughly trained on working with controlled substances and hazardous materials
- All receiving and shipping staff are rigorously trained on handling controlled substances and hazardous materials
Cedarburg Hauser has experience developing and manufacturing the following controlled substances:
- Fentanyl and Fentanyl Analogs
- Cannabinoids
- Oxandrolone
- Butorphanol Tartrate
- Sodium Butabarbital
- Various customer proprietary compounds