Company Profile | May 30, 2012

Cedarburg Hauser Pharmaceuticals

Source: Cedarburg Hauser Pharmaceuticals

Cedarburg Hauser Pharmaceuticals is an experienced, contract development and manufacturing organization (CDMO), specializing in small molecule active pharmaceutical ingredients (API) and pharmaceutical intermediates. Cedarburg Hauser leverages a talented group of scientists and supporting staff, as well as a centralized approach to project management, to ensure on-time and on-budget completion of projects involving the development, scale-up, and manufacturing of complex APIs.

Manufacturing

Cedarburg Hauser Pharmaceuticals offers both GMP and pre-GMP manufacturing services for products ranging from pre-clinical candidates to marketed generics.

Manufacturing Facilities

  • GMP Production Suites
  • GMP Kilo-lab Suites
  • Delta V Process Control
  • Cogeim Filter Dryer
  • Rated Class 100,000 (ICH)

Manufacturing Expertise

  • Controlled Substances
  • Potent Compounds
  • Peptide & Polymer Conjugates
  • Prostaglandins, Vitamin D Analogs, Taxanes, Steroids etc.

Development

The expertise and industry experience of Cedarburg Hauser scientists are critical for the successful development and scale-up of clinical candidates.

Development Expertise

  • Synthetic route optimization
  • Natural product extraction & purification
  • Process validation

Support Services

Cedarburg Hauser Pharmaceuticals offers a full suite of support services to compliment the process development and GMP manufacturing capabilities.

  • Analytical Services
    • Method development, qualification, and validation
    • Stability testing
    • Impurity Identification & Testing
  • Regulatory Support
    • Inspected by FDA, DEA and European Agencies
    • DMF’s and CEPs filed successfully
    • Permits and Quotas for Schedule II-V controlled substances