A great amount of human and material resources are assigned to guarantee the high quality of our R&D, our products and our Service.
Our efforts to comply the highest local and international Quality Standards, have been recognized by obtaining the following certifications:
ISO 9001: 2000 Quality System (TÜV CERT Certification Body)
GMP: Good Manufacturing Practices Certificate for Active Pharmaceutical Ingredients and Finished Pharmaceutical Products manufacturing
US FDA: Facility classified as Acceptable by US Food and Drug Administration
Highest category in R&D: Spanish Technology and Health-care Authorities
ISO 14001: Environmental Management System (TÜV Rheinland)
We comply with the principles of Good Manufacturing Practice in order to obtain products of quality, safety and efficacy.
Our manufacturing plants are periodically inspected by EU Health Authorities and, since 2002, by US FDA. The latest inspections were conducted in June 2011 at INKE and in January 2011 at Laboratorios Lesvi.