Our new facilities, opened in 2009, were designed to allow for flexible and efficient manufacturing processes for small batches. Since then we have been authorized for the manufacturing of investigational medicinal products (IMP) for clinical trials.
We have manufactured a number of batches for different clinical trials, both for innovative products as well as for generics.
We are able to manufacture highly potent drugs as well as low potent drugs and even placebo batches. You can find more information about our high potency capabilities in our High Containment section.
We are GMP certified to manufacture IMP batches in the following dosage forms:
- Tablets (with functional or comfort coating, or without coating).
- Hard gel capsules.
- Powder for oral use (for solution/suspension).
Our maximum batch size is 60 kgs, so we are a suitable partner for innovative drugs in the different clinical stages, from pre-formulation up to Phase I-II-III clinical trials. Idifarma is also an appropriate partner for generic drugs, as we can participate from the beginning of the formulation development up to the manufacturing of the bioequivalence and validation batches, saving time, costs and risks to submit the registration dossier. Moreover, we can also act as commercial manufacturer.
You can find a detailed list of manufacturing equipment in our virtual tour to our GMP Plant.
Additionally, we can also take charge of primary and secondary packaging activities in our facilities. We have extensive experience in clinical packaging projects both for open and double-blind trials. We even have a printer capable of printing directly in the aluminum of finished blisters, offering higher quality and efficiency than labels in blisters. If you are interested in these services, please visit our Clinical Trials Supply webpage.