Medichem’s Malta plant has passed a US Food and Drug Administration inspection without a single observation, meaning its activities have been officially certified to be at the very highest quality level.
No deficiencies or observations were detercted at the Medichem plant
The Barcelona-headquartered group, Medichem is, one of the world’s leading manufacturers of active pharmaceutical ingredients.
The inspection of Medichem’s plant in Ħal Far was carried out by two FDA officers between April 16 and 19 and covered four good manufacturing practice systems, as well as several different active pharmaceutical ingredients that the company exports to the US.
Medichem’s Malta site matched the flawless record of FDA inspections without ‘Form 483’ observations of deficiencies achieved by the company’s Spanish plant.
A ‘Form 483’ is the written FDA report that lists observations and deficiencies found during an inspection. No ‘Form 483’ issued means that neither deficiencies nor observations have been detected.
Medichem has been selling its products in the US market since the 1980s and this year celebrates its 40th anniversary in the global pharmaceutical industry. Since then, the company’s premises have been regularly audited by the FDA.
No ‘Form 483’ has been issued during the last four FDA inspections at Medichem’s Spanish plant which took place in 1999, 2002, 2006 and 2009 and the success has now been repeated at Medichem’s Malta plant.
The 8,800 square metre plant opened in 2005 and currently employs more than 30 staff. Medichem has more than 220 people based in different locations around the world.
Medichem chief executive officer Ervin Veszprémi was delighted, saying: “Having passed the FDA’s scrutiny without any observation means our Maltese activities have now been officially certified to be at the very highest quality level. Who would not be proud of this?”
The Medichem group delivers products to more than 60 countries, including generic and pharmaceutical companies in the United States, the European Union, and Japan, among others.
Medichem’s quality systems, supported by the FDA, the Malta Medicines Authority, as well as ISO 9001 and ISO 14001 certifications, guarantee a consistent follow-up and continuous improvement of the company’s processes.
The company dedicates about 10 per cent of its annual turnover to research and development and the Research and Development department is well known for its expertise in the field of process design, development and optimisation.
Over the last years, Medichem has developed a broad pipeline of new products to meet its clients’ needs. These products are indicated for the treatment of diseases in many therapeutic areas, such as central nervous system cardiovascular, gastrointestinal, ophthalmic and for the urinary tract. Medichem also offers contract manufacturing services.
Medichem has a sister company, Combino Pharm, which manufactures, develops and markets generic pharmaceutical products. Combino Pharm also has a plant in Ħal Far, which began operations in 2006.