CPL is focused on the development and commercial manufacturing of non-sterile liquid and semi-solid pharmaceuticals 

PRODUCT DEVELOPMENT: FORMULATION THROUGH VALIDATION

  • ANDA, NDA, 505(b)2 product development expertise
  • New formula development and re-formulation
  • Reverse engineering for generic product formulation
  • In-Vitro Release Testing (IVRT), In-Vitro Permeation Testing (IVPT), and cell-based & cell-free assay testing for skin models
  • Analytical methods development and validation
  • Process scale-up, optimization and qualification
  • Phase I-III clinical trial supplies manufacturing
  • Technology transfer of current products from other sites

COMMERCIAL PRODUCT MANUFACTURING

  • Non-sterile solutions, suspensions, nasal sprays, lotions, gels, creams, ointments
  • Hormone and corticosteroid product capability
  • Flammable and alcohol-based product processing
  • HDPE and glass bottles, airless bottles (including bag-in-bottle), metered dose pumps, multi-dose pumps, cap closures
  • Aluminum and laminate tubes
  • Foil unit dose sachets
  • Product serialization

 PRODUCT TESTING

  • Nasal spray characterization and release
  • Physical and chemical analytical release testing
  • Elemental Impurities Testing
  • In-Vitro Release Testing (GMP)
  • Microbiology testing
  • ICH stability management

 FACILITIES & EQUIPMENT CAPABILITIES

  • US FDA and Health Canada registered manufacturing and testing sites
  • Segregated manufacturing suites with batch sizes between 20kg-5000kg 
  • State-of-the-art twin Symex manufacturing vessels 
  • Versatile filling lines for plastic and glass bottles 
  • 12,000 S.F of modern chemical, micro, skin testing, and stability laboratories
  • Serving US, Canada, Europe, Japanese, Asian Pacific product markets

Contact us

905.821.7600