January 2013

IDIFARMA has recently obtained a significant extension of its authorization as GMP manufacturer of human use medicines by the Spanish Agency of Medicines and Medical Devices.

With this extension of its authorization as a pharmaceutical laboratory, IDIFARMA becomes a manufacturer of commercial batches of tablets with high level of specialization, due to its high containment requirements (cytotoxics, cytostatics, hormonals), or due to the need of manufacturing small-sized batches. Additionally, IDIFARMA's facilities allow manufacturing under controlled humidity conditions, as well as using organic or aqueous solvents.

During its more than 10 years of history, IDIFARMA has proven its ability to develop medicines for over 100 international clients with different pharmaceutical forms, as well as its suitability for quality control testing and release of pharmaceutical products. In addition to the recent extension of the authorization as manufacturing laboratory, IDIFARMA was previously already authorized for manufacturing batches for clinical trials, as well as for quality control and release of medicines for both commercial and investigational medicinal products.

In the words of its General Manager, Luis Oquiñena, "IDIFARMA will remain essentially a Contract Research laboratory specialized in the comprehensive development of medicines for our clients, but without any doubt, this new manufacturing authorization will allow us to offer an even more complete service beyond the elaboration of the registration dossier, and turns us into a long term partner for our clients".

According to Ángel Ursúa, QP/Technical Director, "this authorization will generate important advantages for products developed in IDIFARMA, whether generics, OTCs or innovative products, significantly reducing deadlines as well as risks in the pharmaceutical development. Moreover, it also allows us to introduce ourselves as an ideal commercial manufacturer for existing products that require a manufacturing facility like ours, either because they need small-sized batches or because of their high containment requirements".

This important extension of its authorization as a manufacturing laboratory shows the success of IDIFARMA's bet on differential capacities such as high containment, as well as innovative technologies for the development of medicines with high level of complexity, as for instance the recent installation of a GEA Niro pilot-scale spray dryer that provides solutions to challenges in the formulation of drugs (solubility, bioavailability, taste-masking, etc.)