IDIFARMA, a leading Spanish Contract Development and Manufacturing Organization, has recently obtained an extension of its authorization as GMP clinical manufacturer by the Spanish Medicines Agency (AEMPS).
With these new GMP capabilities, IDIFARMA is able to manufacture powders for oral use (including powders for oral solutions and suspensions) for clinical trials, as well as tablets and hard capsules.
In addition, IDIFARMA has adapted its laboratory authorization to the recommendations of the new European format for manufacturing authorizations, which came into force on December 1st, and has included the GMP over-encapsulation activities. Over-encapsulation is a very versatile and common solution to blind solid dosage forms for double-blind clinical trials.
Following the clinical manufacturing process, IDIFARMA is also GMP-certified to provide primary and secondary packaging services, quality control testing and QP release, storage, shipment and destruction of medication, and offers specialized services such as blinding strategies design, placebo manufacturing, stability studies and regulatory affairs, which make IDIFARMA an ideal partner for pharma companies with projects requiring a clinical development.
IDIFARMA’s high containment development and manufacturing facilities are authorized to handle high potency compounds (cytotoxics...), as well as to work in humidity-controlled conditions and with organic or water solvents.
IDIFARMA also obtained last year the GMP certification for commercial batches manufacturing of tablets, and accumulates over 12 years of pharmaceutical development experience working with over 100 international pharma companies.
|Last Updated on Tuesday, 28 June 2016 10:28|