Vetoquinol Universal Registration Document 2019

1 Vetoquinol  Universal Registration Document 2019  Financial report   19 PRESENTATION OF THE GROUP Vetoquinol: an industrial Group 1.6 Vetoquinol: an industrial Group The purpose of the production units is to transform raw materials (active ingredients, excipients) into finished products, store and ship them, as well as to manufac- ture active ingredients. These processes are carried out under conditions that guarantee product quality, safety and efficacy. In 2019, Vetoquinol manufactured close to 25 million products in a variety of forms: • sterile injectable liquids; • drinkable liquids; • powders and pellets; • pastes and creams; • tablets; • drug premixes; • soft chews. As of December 31, 2019 Vetoquinol had seven produc- tion units. Generally speaking, Vetoquinol’s international sales sub- sidiaries lease the buildings they occupy. All Vetoquinol plants have GMP approval for their spe- cific manufacturing operations, except for Tarare which only manufactures non-medicinal products. In addition, the Princeville plant in Canada is FDA-certified. In the case of products which it lacks the technical capa- city to produce, Vetoquinol uses subcontractors, who are monitored and audited by the Vetoquinol industrial department to ensure they apply the same standards of compliance as the Group’s own plants. Vetoquinol also distributes other companies’ products, which are regularly monitored and audited by the indus- trial department. A systematic quality approach has been implemented throughout all Vetoquinol production lines, reflecting the importance of people in this respect: there is one person in quality (quality assurance or control) for every two people in production. In particular, quality control involves: • the inspection and release of raw materials and pac- kaging items; • the inspection and release of finished products; • water, air and environmental compliance. Quality assurance ensures that the Group’s plants and external manufacturers are in compliance with all phar- maceutical standards (GMP, FDA, PMDA, MAPA, FAMI QS, ISO), as well as the implementation of adequate resources (materials and equipment, personnel and organization, premises and flows) in terms of numbers and quality. 1.6.1 France (Lure, Tarare, Paris and Angers) The Company owns the Lure complex (Magny-Vernois). The site covers an area of nearly 16 hectares, including over 24,000 sqm of built areas (floor area), or nearly 37,000 sqm of developed area. It houses the Company’s head office, industrial activities, R&D, logistics and Group functions. Veterinary drugs and non-medicinal products for the entire global market are produced here. This unit produces sterile injectable liquids, non-sterile liquids and creams, and tablets. The Tarare plant occupies a 10,000-sqm site with two built areas totaling 4,000 sqm. Vetoquinol owns the premises. In February 2014, the Company signed a com- mercial lease for offices in Paris (located at 37 Rue de la Victoire), which house the France Department and certain Group functions. In September 2018, the Company acquired an R&D center near Angers. This site occupies an area of approximately 100 hectares of leased farming land. Classified facilities The Lure site is subject to the following provisions rela- ting to facilities classified for environmental protection (ICPE) under the dual regime of reporting and registra- tion following the revisions of the ICPE nomenclature in 2006 and 2010. The site is operated in accordance with its updated authorization order taking into account the site’s recent extensions. Lure is the subject of regular inspections by depart- ments at DREAL, most recently on September 20, 2016. The site is not affected by the provisions of the Seveso directives. In absolute terms, all drugs and their active ingredients are liable to present environmental risks; however, the drugs manufactured by Vetoquinol do not present any specific or higher risks than the human or veterinary drugs on the market.