Tablets (coated or uncoated, aqueous process or organic), Capsules (powder, pellet or liquid fill), powder in bottle, liquids, semi-solids, all can be manufactured under cGMP conditions.
Manufacturing processes that include hot-melt extrusion, spray-drying to form amorphous dispersions, high-shear granulation, tablet and particle coating, milling, blending, and all other standard processes for solid oral dosage forms can be accomplished by our Manufacturing Team.
We also have experience in manufacturing of topical and oral liquids, gels and semi-solids, and oral films.
Our GMP manufacturing suites are validated to Class ISO 8 conditions as defined in the International Organization for Standardization’s ISO 14644-1 Standard for Clean Rooms. This is the equivalent to US Federal Standard FED –209E Class 100,000.
All equipment used in these suites have been installed, validated and maintained as required by GMP regulations, and all personnel have required, documented training for these procedures.
Stand-alone GMP Manufacturing
In addition to manufacturing formulations developed internally, Formex can perform stand-alone GMP manufacturing of existing dosage forms by transferring in the processes, and validating them as needed for the phase of clinical examination for which they are intended.