Utilizing the best of our experiences, business acumen and quality care to provide responsive and efficient pharmaceutical manufacturing and distribution infrastructure.
Demonstrated success supplying 3 billion immediate and controlled release tablets / capsules with DEA, solvent, and HPAI processing capabilities.
Oral solid dose, powders, and liquids packaging in bottles with serialization of primary / secondary labeling and cartoning (unit and aggregate).
Clinical Trial Materials
Adaptive formulation technologies for Phase I - IV clinical trial materials manufacturing with packaging in dose-packs or clinical kit assemblies.
Employing our know-how, technology, and innovative ideas in the development of immediate and modified release oral solid dose, liquids and suspensions.
Leading in the implementation of complex processing, fluid bed drying, Würster and top-spray coating, drug-layering, mini-tablets, pusatile extended release.
Collaborating with our clients to ensure successful process transfers, anticipating equipment capabilities and ensuring Quality by Design principles.
Experience is key in anticipating and interpreting the best approaches to regulatory approvals. Our team can help streamline the application approval process.
Demonstrating experience, efficiency and technical proficiency in the development / validation of analytical methodology and GMP testing support.
Method evaluation and implementation for chromatography, dissolution, and monograph techniques (USP/NF, ASTM, EP, BP, JP and CP)
GMP Testing Services
High proficiency in the GMP testing of Active Pharmaceutical Ingredients, excipients, and finished products.
Stability and Storage
Large capacity stability storage and testing under ICH controlled conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH) and ICH-compliant photostability studies.
Reduce drug-layering production time & costs
Frontida’s Duragran® process allows us to create controlled release beadlets / granules of uniform and narrow particle size range without the use of spheronization / extrusion equipment or the need to layer product onto a uniform sized sugar bead. The patented process creates granules of more uniform particle size than a standard wet granulation process with easily modified process parameters that can be used to target a desired particle size. The technology can be applied to controlled release formulations and to create taste-masked, orally disintegrating tablet formulations.
The benefits of the patented process are a reduction in the number of process steps and time needed to create a defined granule particle size distribution range. Production costs, energy requirements and Quality Unit in-process monitoring can all be reduced by employing this technology.
Highly flexible, multi-delivery platform
Frontida’s AdaptDose™ technology platform provides a tool that can eliminate the need to reformulate after Phase I and overcomes several technical hurdles in the development and scale up of (1) new molecules, (2) binary and tertiary mixtures of active ingredients, zero and first order drug release matrices, or (3) scalable clinical trial materials used in dose ranging or adaptive dose clinical studies.
Our unique commercialized approach to adaptive formulation design provides the ability to combine 2-3 active ingredients or 3-4 delivery rates in a single capsule using minitabs, beads, granules, and liquid.