Cedarburg Hauser Pharmaceuticals

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 with developing and manufacturing the following controlled substances…

 

  • Family of Fentanyl compounds (Fentanyl base, Fentanyl Citrate, Sufentanil, Remifentanil and Fentanyl Conjugates)
  • Delta-9-THC
  • Oxandrolone
  • Butorphanol Tartrate
  • Sodium Butabarbital
  • Various customer proprietary compounds


Next Steps…

 

If you are developing a controlled substance we would like to talk with you about how Cedarburg Hauser can use our experience and expertise to help you make your project a success.  This e-mail address is being protected from spambots. You need JavaScript enabled to view it now to discuss your project!