has obtained an extension of its authorization as a GMP clinical manufacturer by the Spanish Medicines Agency (AEMPS) to include new dosage forms. The expanded GMP capabilities allow for the manufacture of powders for oral use (including powders for oral solutions and suspensions), as well as tablets and hard capsules. IDIFARMA has also adapted its lab authorization to the new European format for manufacturing, including GMP over-encapsulation to blind solid dosage forms for double-blind trials.
The company is also GMP-certified to provide primary and secondary packaging services, quality control testing and QP release, storage, shipment and destruction of medication, as well as services such as blinding strategies, placebo manufacturing, stability studies, and regulatory affairs. IDIFARMA’s high containment development and manufacturing facilities are authorized to handle high potency compounds, as well as humidity-controlled conditions with organic or water solvents.