Contract Development and Manufacturing
Our Capabilities
From concept to reality, Chattem Chemicals can get your API to the market. Having Research and Development, Engineering, Manufacturing and Quality Control all at the same location, we are able to keep your project on track through timely collaboration and communication.
We have current registrations and are in good standing with the FDA, DEA, and all other necessary regulatory agencies. We have the capability to manufacture both controlled and non-controlled substance APIs.
Our goal is to ensure your project is completed on time and under budget while maintaining the highest quality standards. As our partner, you are kept up to date on process and results throughout the lifecycle of the project.
Tell us about your next opportunity!
Our Contract Development and Manufacturing Includes:
  • APIs
  • Flavors & Fragrances
  • Oil Field Chemicals
  • Aluminum Complex Greases
  • Catalyst Supports
  • Plastic Additives
  • Printing Ink
  • Coatings

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Note: If you need a MSDS, Technical Data Sheets, NSF certificates, or a Kosher Certificate, please contact the appropriate business manager.
Two guys viewing reactor
R&D
Whether you hit a roadblock in your API development, or need a partner from the start, we can help. The technical and analytical expertise of our highly skilled R&D Chemists can take your challenge and make it a reality. Our R&D department can provide services such as KSM assessment, lab scale batch production, scale-up activities, impurity identification, pilot to validation activities and more. Chattem’s instrumentation capabilities include LCMS, GCMS, ICPMS, UPLC, FID TCD GC, Malvern 3000, TOC w/connectivity.
Process Engineering
Chattem Chemical’s highly skilled process engineers aid to ensure a smooth transition from R&D to manufacturing batches. They oversee your project from raw material procurement through the final stages of the manufacturing process. Their experience allows them to see potential issues before they arise helping to keep the process always moving forward.
Manufacturing
Whether Chattem Chemicals helped developed the API or if it was a technology transfer, our cGMP manufacturing facilities can assure your API is produced to meet all specifications and regulatory requirements. Our facility boasts stainless steel, glass and hastelloy reactors ranging from 20 liters to 2,000 gallons. Having multiple dryers, centrifuges, mills and other necessary equipment ensures your project stays on track without delay waiting on equipment to be available.
Quality Control
Chattem Chemicals employs highly trained lab technicians and chemists with experience ranging from fresh out of college to 46 years of experience on the bench. Our laboratory employees coordinate with manufacturing and engineering to assure products meet customer specifications and R&D to transfer new test methods into the Quality Control lab. Our QC lab is equipped with a variety of instruments including HPLC, GC, ICPMS, Malvern, LCMS, GCMS, UPLC, IC, polarimeter, and AAA. All of our technicians and chemists are trained to perform all testing including chromatography, spectroscopy, particle size analysis, and many different wet lab techniques.
Employee Health & Safety
Chattem Chemicals requires strict adherence to all EHS protocols. We have recently celebrated 18 YEARS without a Lost Time Accident. Employee safety is one of our pillars of excellence.
Regulatory
Chattem has a strong history of meeting and exceeding regulatory requirements. We have regulatory experts on site to make sure there are no unforeseen issues that arise to compromise your project. We maintain good standing with the FDA and DEA. Our most recent FDA and DEA inspections reported ZERO observations or 483s. Additionally, our regulatory experts maintain multiple Drug Master Files (DMFs) with the USFDA and various regulatory bodies worldwide.
hard hat people looking at reactor settings employee hand opening reactor