Interview with Dino Mangion, Plant Manager, Medichem (Malta)
Medichem began production at its plant in Malta in 2006. Can you give us a brief overview of the facilities, and of the importance of the subsidiary to Corporación Medichem…
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Medichem is a Spanish, privately owned company based in Barcelona, engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical industry since the early 1970s.
Our business model is built around our partners who we aim to please with pro-actively timed, right quality products, carefully avoiding intellectual property infringements. This we can only achieve through the creative thinking of our people, which really is the key to success.
Our partners are principally generic drug companies and pharmaceutical firms worldwide for whom we have developed a strong pipeline of new products that addresses the treatment of diseases in almost all therapeutic areas. We supply them with a wide range of high quality generic and custom manufactured APIs in volumes that range from a few grams to hundreds of tons.
We are a cGMP compliant company with a long and successful history of inspections. This includes regular US-FDA inspections of our plant in Celrà (Girona), Spain since 1985. The last four of these inspections, namely in 1999, 2002, 2006 and April 2009, were “no form 483” rated (no observations were noted).”
Our quality and environmental systems, and working practices supported by the FDA, the ISO 9001 and ISO 14001 certifications, guarantee a consistent follow-up and continuous improvement of our processes.
We have a sister company, Combino Pharm, which has generic formulation, development and manufacturing capabilities, giving us a unique insight for the understanding of the overall generics industry.
We are one of the world’s most respected independent Active Pharmaceutical Ingredients (APIs) suppliers and are headquartered in Barcelona, Spain. Our two manufacturing sites are located in Spain and in Malta. In Spain, we have been regularly inspected by the FDA since 1985, the last four inspections (1999, 2002, 2006 and April 2009) had no “Form 483” issued.
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