At Seratec, our state-of-the-art manufacturing plant is dedicated to producing active pharmaceutical ingredients (APIs) with an unwavering commitment to quality and safety. Certified by leading global regulatory agencies—including the U.S. FDA in 2003 and the French ANSM in 2007—our facility upholds the highest international standards.
Before any production can begin, each manufacturing site must secure the necessary authorizations and pass rigorous inspections mandated by international health authorities. In the U.S., the FDA, recognized as the world’s most stringent regulatory agency, oversees this process. For products marketed in Europe, the European Medicines Agency (EMA) provides oversight, with the ANSM acting as its representative in France, one of the strictest regulatory bodies within the European Community. In compliance with Articles L. and R. 5138 of the French Public Health Code (CSP), all manufacturing activities involving active substances in France must be officially authorized and declared.
A critical component of maintaining these high standards are the Good Manufacturing Practice (GMP) inspections, which can occur before or after product approval. These inspections are essential because any compromise in the quality, safety, or efficacy of our products could lead to the immediate withdrawal of authorization and a halt in production.
The design and construction of our facility are fundamental to achieving and maintaining these rigorous standards. Our plant is commissioned only after a thorough verification process confirms that its construction meets stringent design criteria. This process includes multiple stages of qualification to ensure that the facility is fully compliant and capable of producing safe, effective products. Compliance begins at the design phase and continues throughout the facility’s entire lifecycle.
This way, our rigorous approach covers every aspect of facility engineering, from the qualification of equipment and systems to the validation of manufacturing procedures. These steps are essential for a successful marketing authorization application for the final medicinal product.
Our plant currently houses three specialized workshops, with more under development by our engineering team:
Production: Capacities ranging from 200 litres to 1 m³
Pilot: Capacities from 100 to 200 litres
Kg Lab: Capacities from 60 to 100 litres
Each workshop is equipped with a dedicated drying room under controlled atmosphere (Class C) and adjacent utilities to ensure efficient flow of materials, staff, and equipment. This design anticipates and meets the evolving requirements of pharmaceutical chemistry, enabling us to maintain compliance with all legal and regulatory standards.
Environmental protection is a core principle guiding the operation of our entire plant and business. We conduct thorough environmental impact assessments for all active ingredients and materials processed at our facility.
Furthermore, our facility design consistently meets and exceeds environmental, safety, and regulatory requirements, ensuring continuous improvement and safeguarding the interests of our customers, patients, authorities, and staff.
The Pharmaceutical Quality System (PQS) is a management framework ensuring consistent production of high-quality products.
Quality at Seratec plays a crucial, cross-functional role. For us, quality isn’t just a goal—it’s a driving force behind everything we do.
At Seratec, our expertise begins with the molecule and extends all the way to the active pharmaceutical ingredient (API).