Fagron Industry Foreword Fagron worldwide Fagron provides the best in innovation, Fagron is fully compliant with the Falsified solutions and quality and has been able to Medicines Directive. In force since 2 July secure an exclusive position in everyday 2013, this requires written authentication to healthcare. This allows our customers to accompany each import of an API from a EUROPE adequately respond to the growing country outside the EU and ensures patient USA 8 sites worldwide need for tailor-made medication. safety and controlled trading. We only 3 sites GMP, FDA, ISO9001 approve suppliers that have successfully GMP, FDA Our extensive range of innovative vehicles completed the Fagron Group Supplier developed by Fagron R&D and over 5,000 Qualification process, including on-site Active Pharmaceutical Ingredients (APIs), audits. excipients, inflammables and herbs are daily CHINA In only 20 years, Fagron developed from a accessible, globally for the pharmaceutical, Over 160 Fagron pharmacists are continually purchase & local player to become the global market veterinary, food, nutraceutical and cosmetic developing new, unique products and quality office leader for specialised pharmaceutical industries. Our offer also includes an concepts to meet the growing worldwide solutions. With over 1,500 employees extensive range of other products, such as demand for tailor-made medication. We are active in 60 countries worldwide, Fagron packaging materials, capsules, appliances, a R&D scientific company that is fully provides over 200,000 customers balances and miscellaneous laboratory committed to optimisation and innovation worldwide with high-quality products, instruments and utilities. With our in pharmaceutical solutions. Our dedicated concepts and solutions. pharmaceutical raw materials, innovative approach has recently led to the BRAZIL vehicles and wide range of services, we not development and introduction of a new and 4 sites only guarantee product quality, but also extensive generation of innovative vehicles GMP, FDA, ISO9001 ensure ease of use. that are introduced globally. We invite you to read about the benefits and qualities of FAGRON GROUP We offer raw material conditioning these new products in the Fagron 5,000 pharmaceutical raw materials according to specific production Innovative Vehicles Flyer. 15 sites requirements, the highest quality raw materials from reputable producers and Fagron, the global market leader for third-party compounding and contract specialised pharmaceutical solutions! manufacturing. All of our activities comply with comprehensive documentation, in line Ger van Jeveren, with current GMP/GDP directives. Founder and CEO Fagron Group From local player to global market leader and Fagron mission consolidator in the market of pharmaceutical and strategy compounding in only 20 years Fagron’s strategy is focused on the optimisation and innovation of Fagron Executive Committee Fagron was founded in Rotterdam (the Netherlands) in 1990 by Ger van Jeveren, the current pharmaceutical compounding. CEO of the Fagron Group. Through a continuous focus on innovation, quality and solution- As a R&D scientific pharmaceutical oriented thinking, Ger van Jeveren brought market leadership in pharmaceutical compounding company, Fagron wants compounding to Fagron in the Netherlands in just 7 years. to widen the therapeutic scope of the prescriber to enable tailor-made Ger van Jeveren continued to direct further development and international growth, with the pharmaceutical care. Through its result that Fagron is currently the global market leader and active in 30 countries in Europe, activities, Fagron supports the unique the Americas, the Middle East, Africa, Asia, and the Pacific. Fagron products are sold over selling point of the pharmacist and Ger van Jeveren Constantijn van Rietschoten Michaël Hillaert Rafael Padilla 200,000 customers in over 60 countries around the world. improves the patient’s quality of life. Founder and CEO Marketing, Innovation and Area Manager Germany, Area Manager South America, Business Development Poland, Nordic, France and Italy and Iberica Market leadership provides major competitive advantages, such as the central procurement Fagron business model Belgium of raw materials, optimal utilisation of production facilities, and the international roll-out of successful and innovative products and concepts. With over 1,500 employees, Fagron generated a turnover of US$ 400 million in 2012. Fagron intends to further reinforce its worldwide market leadership based on an active buy-and-build strategy, starting up greenfields and robust organic growth. Jan Peeters Karin de Jong René Clavaux Erik Hoppenbrouwer Finance Controlling Information Management Operations * Fagron Compounding Services Fagron values Fagron unique added values Our values define what we are and what we Combining the forces raw materials globally while operating close aim to be. They reflect the way we should to the production sites. This results in full operate both internally and externally. of procurement, traceability and a high standard of quality. Our values give us standards to measure manufacturing and On-site producer audits, (re)qualifications ourselves by, particularly in our dealings and regular performance assessments with customers, suppliers, our own people quality management guarantee continuous control of Fagron’s and the wider world. The values have real product portfolio. Securing that meaning for us and the way we behave. More than 200,000 customers worldwide pharmaceutical raw materials quality is in have access to over 5,000 high-quality accordance with the latest editions of pharmaceutical raw materials thanks to worldwide pharmacopoeias, and ensuring We believe in: Fagron’s global product and producer that all pharmaceutical raw materials in • Customer is number 1 qualification, full analysis of incoming and Fagron’s range are produced in factories needs in a manufacturing network that produced products, GMP conditioning and which are inspected by regulatory agencies includes its own production facilities and • Entrepreneurship release by a qualified person. This unique including FDA, EMA and ANVISA, and are contract manufacturers on three continents, • Speed of execution position makes Fagron attractive to GMP-compliant, is essential to Fagron’s being all meeting the latest national and pharmacies, hospitals and the able to guarantee its high quality standards. international standards (GMP and GDP). • Results-driven pharmaceutical, veterinary, food, Pharmaceutical raw materials are subjected Regular audits are performed internally and • Innovation nutraceutical and cosmetic industries. to a rigorous process of tests. The results of by third parties. these tests and the extensive range of • Behave as a global Procurement documents Fagron demands from producers At 15 sites with more than 150 clean rooms, market leader Fagron has sourcing offices in South America, are reviewed by a qualified person before Fagron manufactures creams, syrups, North America, Europe and, in 2012, Fagron products are released. compounded medication and other high opened a sourcing office in Shanghai (China). quality products for pharmaceutical This brings Fagron closer to the world’s Manufacturing purposes. These products come in a wide biggest producers of pharmaceutical raw Fagron produces standardised products as range of packaging including containers, materials so it can source its pharmaceutical well as products tailored to specific customer tubes, bottles, syringes and blisters. Quality management From selecting a producer until delivery of a Fagron product to the customer, Fagron Quality goes through multiple steps as the following table shows. Fagron employs over 160 pharmacists worldwide. Within Quality Management, there are over 140 professionals who maintain and ensure Fagron’s high quality standards. QUALITY TASKS QUALITY TASKS Quality (in coordination with Procurement) Quality (in coordination with Sales) Set up confidentiality agreements with producers Handling complaints Producers qualification Handling recalls Products qualification Audits of producers Quality (in coordination with Production) Quality (general) Incoming product analysis Manage quality system Manage out of specifications Write and implement global procedures Incoming product release Keep site master file Perform and review in-process controls Communication with competent authorities Perform stability testing Host competent authorities’ audits Process validation and calibration Stay updated on new regulations Handling deviations Host audits from customers Manage change control Perform internal audits Implement corrective and preventive actions Provide GMP training Approve labelling Quality helpdesk Review production data and documents and release/reject produced products Product quality review Check and publish MSDS Perform risk assessment Check warehousing Obtain manufacture licences and certificates Check transports (GDP) Set up vendors’ technical agreements To go even further in meeting our customers’ needs, Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and technical specifications are available for all our products online (fagron.com) or upon request. Fagron innovative solutions Fagron assortment 100132 Amoxicilline trihydr. G RAW MATERIALS 100133 Amphetamine sulfate (DL-) G 100448 18 Beta Glycyrrhetenic acid G 103703 Amphisol K / Potassium cetylphosphate G 105611 7-Keto DHEA G 100134 Amphotericin B G 102974 Abil® antistatic