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
