Quality and Safety

Quality stands in the middle of our logo and intersects everything we do.

Quality defines who we all are and what we do. 

Quality stands in the middle of our logo and intersects everything we do. It gives us standards to measure ourselves by, particularly in our dealings with customers, suppliers, team members and the wider world. Fagron combines local expertise with global innovation in 60 countries worldwide. 

Our in-house expertise, quality, and safety mechanisms allow us to be able to develop formulations that ensure our products meet all the necessary standards. Fagron’s presence in different markets means we have to comply with the different local regulations. With the use of MasterControl quality system, we are able to streamline all quality processes and ensure the same standard process in all facilities, from the supply chain of the raw material, production, quality management, all the way to the customer. 

More than 200,000 customers worldwide have access to over 2,500 high-quality pharmaceutical raw materials thanks to Fagron’s global product and producer qualification, full analysis of incoming and produced products, GMP (Good Manufacturing Practice) conditioning and release by a qualified person.  

Master Control

Suppliers and production

At Fagron, we produce standardized products and products customized to specific customer needs, in a manufacturing network that includes our own production facilities as well as contract manufacturers on three continents. All production processes, both our own and contract manufacturers, meet the latest national and international standards (GMP and GDP). GMP and GDP are governed by the local governmental bodies, such as FDA, European Commission, and Anvisa, and all Fagron companies comply with their respective local regulation and standards.

With offices in Latin America, North America, Europe, and Asia, we source pharmaceutical raw materials globally while operating close to the production sites of pharmaceutical raw materials. This results in full traceability, high standard of quality, and consistent inventory. On-site producer audits, (re)qualifications and regular performance assessments guarantee continuous control of Fagron’s product portfolio.

Besides qualification based on documentation, Fagron also conducts internal and external audits to ensure consistency of the high-quality standard we deliver to our partners. The internal audits are performed to ensure compliance with local and global legislation and with Fagron’s internal procedures. The external audits are conducted among producers, agencies, third-party laboratories, and distribution companies. This is to ensure that our partner companies maintain the same quality standards as we do, and that they will therefore contribute to the high quality of Fagron products.

Learn more about our partners in production

Production in numbers

API's
1000+
global products
375
suppliers
4,000+

Quality control

To guarantee our high-quality standards, we ensure that the pharmaceutical raw materials quality is in accordance with the latest editions of worldwide pharmacopoeias and that they are produced in GMP-compliant factories. Pharmaceutical raw materials are subjected to a rigorous process of tests. The results of these tests and the extensive range of documents Fagron demands from the producers, are reviewed by a qualified person before release.

What we are and what we want to be, is defined by our values. They exemplify how we should conduct ourselves both inside and outward. Our values provide us with benchmarks by which we may assess ourselves, particularly in our interactions with customers, suppliers, our own employees, and the rest of the world. For us and the way we act, the values have actual importance.

To meet the needs of our customers, we have made all Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and technical specifications available on our documentation page.

View product documentation page

Quality control in numbers

stability studies
200+
compatibility studies
375
pharmacists
400+