Corealis Pharma
Corealis Pharma specializes in the development and manufacturing of pharmaceutical oral solid dosage forms, focusing on early-phase clinical trials and API development.
Company Overview
Corealis Pharma specializes in the development of pharmaceutical oral solid dosage forms and the manufacturing of Phase I/II clinical supplies. The company offers expertise in API characterization, formulation development, and the manufacture of early-phase clinical trial material. Corealis Pharma provides comprehensive solutions for turnkey projects covering the entire characterization-to-clinic process, supporting API development at all stages of the solid dose development cycle.
Services
Corealis Pharma provides a range of services aimed at high-quality pharmaceutical development. These services include API characterization, pre-formulation, formulation development, and manufacture of early-phase clinical trial materials. Advanced capabilities encompass tableting, encapsulation, dry and wet granulation, amorphous enabling technologies, extrusion and spheronization, and coating. Additionally, the company offers specialized capabilities in clinical formulation development and clinical supply manufacturing, supporting clients through all stages of drug development.
Facilities and Equipment
Corealis Pharma operates advanced facilities that include a 15,000 sq. ft. area dedicated to clinical supplies cGMP manufacturing and a 30,000 sq. ft. laboratory for pre-formulation and formulation development work. The company utilizes specialized equipment for pre-formulation and analytical work such as UPLC, GC, dissolution equipment, XRPD, DSC, TGA, SEM, particle sizers, and PAMPA. The GMP manufacturing area consists of production modules with individual HVAC systems to minimize cross-contamination risks.
Clinical Manufacturing and Packaging
Corealis Pharma offers a range of clinical manufacturing and packaging services specifically for pharmaceutical oral solid dosage forms. These services include tableting, encapsulation, dry and wet granulation, amorphous enabling technologies, extrusion and spheronization, and coating. The company provides analytical services that support formulation development and clinical supply manufacturing, ensuring phase-appropriate drug products that meet both client and regulatory standards.