APIs and advanced intermediates manufacturing

Custom synthesis and purification systems for active pharmaceutical ingredients.

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:

• Services: custom API synthesis and purification services in our 6 FDA-inspected API manufacturing facilities.
• Products: Generic APIs (such as Paclitaxel, Nitroglycerine and others), and fine chemicals (special reagents and building blocks)
• Systems: Preparative and process scale chromatography systems and membrane filtration systems

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:

• Chiral technologies,
• Hazardous chemistry,
• Highly potent active ingredients,
• Process chromatography,
• Advanced organic synthesis.

Novasep API manufacturing solutions - your benefits

Time efficiency and cost-effectiveness

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:

• Our special chemical technologies will often enable us to reduce the number of chemical steps, thereby increasing yields and lowering the overall synthesis cost and time,
• Our expertise in separation technologies and our proprietary chromatography technologies enable to get quick access to pure intermediates and active pharmaceutical ingredients, and to guarantee their scale-up, on our site or at yours,
• We have an efficient sourcing team and a network of reliable suppliers in Asia that we regularly audit, to access competitively priced raw materials and intermediates.

Flexibility

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.

Safety and Regulatory Compliance

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.

Industry Leading Project Management

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:

• Optimized communication between the customer & Novasep:
• Align strategies and objectives
• Share and assess risks 
• Be transparent
• Established change management process
   
• With a professional project team:
  • Composed of experts from each department with complementary skills
  • Able to set ambitious, yet realistic objectives
  • Able to assess and accept risks
     
• Led by a professional project manager, who:
  • Leads the project team
  • Promotes team spirit
  • Manages the interfaces between Novasep’s sites / departments and the customer to meet project specifications
  • Ensures smooth communication within Novasep and with the customer. This is particularly important in a number of complex projects that involve multiple sites and teams.

Download our brochures for API synthesis and purification.

Contact us for any API and advanced intermediates production request.