We address all your preclinical, clinical and commercial production needs for any Active Pharmaceutical Ingredient (API) and advanced intermediate, including Highly Potent Active Ingredients (HPAPIs), applicable to all therapeutic indications.
Our innovative API manufacturing solutions are available on a scale from one kilogram to hundreds of tons, whether you want to in-source or outsource your API production through our:
Thanks to our extensive experience and our strong capabilities in fine organic chemistry, we can provide you with products and services that perfectly match your needs for API and advanced intermediates manufacturing using our unique palette of technologies:
With greater economic pressures, tougher competition and increasingly stringent quality and regulatory requirements, the challenge is to reduce process development time while minimizing costs and the environmental impact of the API manufacturing route. Our solutions help to meet these requirements:
We have established a flexible organization to address your manufacturing needs and to provide you with the appropriate solutions in the minimum amount of time. This is possible thanks to our various operating sites; the diversity of our teams and their complementary expertise; as well as our wide range of equipment from lab to industrial scale and our fine chemicals available in various quantities.
The pharmaceutical industry cannot compromise when it comes to quality and patient safety. Our solutions are compliant with all regulatory requirements and ensure the highest quality and safety level while optimizing purity and yield.
All our cGMP production facilities are regularly audited by our customers and all applicable regulatory bodies including the US FDA. We combine pragmatic and rigorous approaches to all disciplines including equipment and facility design; process design and development; and process validation. We provide all necessary regulatory support to you, either in the form of assistance to draft your CMC section or through the filing and maintaining of our own DMFs.
As a world leading API manufacturer using a broad range of hazardous or energetic chemical steps, we have developed stringent facility design concepts, reaction safety testing and standard operating procedures whose efficiency has been demonstrated by our exceptional track record of safe production over several decades. Our expertise in manufacturing highly potent ingredients is backed by a recently obtained SafeBridge® certification.
Our customers require our utmost performance in terms of quality, quantity, time and cost. Moreover, being involved in approximately 100 development projects at any given time, we have to deliver operational excellence systematically.
In this aim, we have developed a specific organization and procedures (up to 400 specific tasks are defined, depending on the project scope) to manage custom synthesis and purification projects, based on the following concepts:
Discover our offering for APIs:
Download our brochures for API synthesis and purification.
Contact us for any API and advanced intermediates production request.