API manufacturing
API manufacturing
Small molecule API manufacturing is a complex challenge requiring chemistry expertise as well as specialized facilities, regulatory experience & supply chain management.
That’s why pharmaceutical innovators are today relying more and more on CDMOs (Contract Development and Manufacturing Organizations) for the manufacturing of their API (Active Pharmaceutical Ingredient). Indeed, working with CDMOs allows drug companies to benefit from a long-term partnership with an experienced team offering specific skills, equipment, capabilities, and technical resources that are not available internally, resulting in a robust and secure supply chain, reducing risks and optimizing costs.
But selecting the best supplier for an API manufacturing project is not always straightforward.
Here are some of the key considerations when choosing a CDMO partner:
A reliable CDMO partner for API manufacturing
For more than 30 years, Novasep has been a leading CDMO in the API (Active Pharmaceutical Ingredient) arena capable of providing unique services for drug substance manufacturing, from clinical to commercial.
With an experienced team of chemists, Novasep:
- Manufactures more than 40 commercial APIs & advanced intermediates per year
- Transfers more than 50 process steps from R&D to manufacturing each year
- Offers its extensive validation experience: more than 10 customer products manufactured on our sites received FDA approval in the last 4 years
Our API manufacturing services
Keeping your clinical program on-track requires an experienced Project Manager coupled with expertise and specialist capabilities. Novasep offers a full range of CDMO services for APIs to pharmaceutical innovators from kilograms up to hundreds of tons.
Regardless of the development phase of your API, we offer seamless development & scale-up services to provide robust long-term manufacturing solutions.
To support your drug manufacturing and be prepared for your commercial launch, our cGMP services include:
- , and production scale
- Clinical & commercial manufacturing
- Process validation
- A wide range of flexible reactor trains from 100L to 12.5m³
- Multiple API sites
- Clean rooms class 100’000
- ICH stability studies
As you work to bring your product to market, we aim at continuously streamlining and optimizing your production processes to offer cost-efficient solutions.
A dedicated Project Manager is assigned to each project to ensure the objectives are met (quality, costs, timelines) and to support you along your API manufacturing journey.
Specific expertise for API manufacturing
Manufacturing your API with us also means leveraging advanced technologies such as:
We are also a reliable and experienced manufacturing partner for Palladium cross-coupling reactions such as Buchwald, Cyanation, Heck, Sonogashira & Suzuki, … and for many other reactions.
