Cedarburg Hauser Pharmaceuticals has the experience and capabilities to help you with either taking your API from the bench to market or simply take your existing process and generate the material you need for toxicity and clinical testing.

Manufacturing Equipment & Capacity

Process Development Laboratory Equipment

4 GMP searate production suites
4 GMP kilo-laboratory suites (2 high potent facilities)
Isolated drying / packaging room
Rated class 100,000 (ICH)
30 gallon reactor
50 gallon reactor
100 gallon reactor
300 gallon reactor
500 gallon reactor
Cogeim filter dryer
Delta V process control (validated)
Stability chambers (IHC)

21 R&D fume hoods
Analytical support laboratory
Glassware synthesis up to 50L
DSC
HPLC / UPLC
Lab to commercial scale chromatography
Lyophilzation
Hydrogenation
GC Mass Spec
LC Mass Spec
300 MHz NMR
Ozonizer (up to 100g per hour)

Need help developing synthetic routes and manufacturing processes for your API?

Cedarburg Hauser Pharmaceuticals is the ideal solution for companies that need help developing synthetic routes and manufacturing processes. Our project teams are lead by Ph.D. study directors with 10-20 years of drug development experience in large pharmaceutical companies (e.g., Abbott, Pfizer, Eli Lilly, UpJohn) and work closely with our chemists and project management team to routinely develop, scale and validate novel synthetic routes for clients, and oftentimes exceed desired yields and purities.

Already have a process and just need material generated for toxicity and clinical studies?

Instead of requiring new process development, some companies already have well-developed processes for their drug substance and simply need their API material to be generated for toxicity or clinical studies.

Cedarburg Hauser Pharmaceuticals can be a valuable partner, using our extensive experience in scale-up and validation projects. For these projects, Cedarburg has a team skilled in developing robust processes amenable to validation and generation of commercial volumes. We have over 25 years of experience validating synthetic processes and providing regulatory documentation in support of CMC filings.

Centralized project management makes a BIG difference to your success.

Strong project management allows Cedarburg Hauser Pharmaceuticals to succeed where others have failed. Complex projects with aggressive timelines require a business mindset and detail-oriented oversight, all managed from a central point that ensures all the resources are in place at the right time and every member of the project team is clear about what needs to be done.

Our unique centralized project management system, coupled with the technical expertise and creativity of our scientific staff, ensure timely completion of individual milestones and routinely results in meeting or exceeding project objectives in terms of process development, validation and API material delivery.

Get more details on why CHP’s centralized project management system is so successful.

Contact us today about your API development project

Headquarters:

870 Badger Circle
Grafton, WI 53024 USA
1.262.376.1467
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Colorado Facility:

6880 N. Broadway, Suite H
Denver, CO 80221 USA
1.720.406.4887
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Tell us what we need to do to compete for some of your business.

Or you can always talk to one of our experienced project managers by calling us at 1.262.376.1467 -- just ask for Mark.