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.
A reliable CDMO partner for API manufacturing
For more than 30 years, Axplora 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, Axplora:
- Manufactures more than 40 commercial APIs & advanced intermediates per year;
- Has validated more than 50 chemical steps in the last 3 years;
- Has manufactured more than 10 customer products that received FDA approval over the last 5 years
- Why Axplora is a trusted API manufacturing partner?
- Outstanding quality assurance track record
- Multi-site API manufacturing capabilities
- Expertise in specialized technologies
- Broad toolbox of classical chemistry
- Flexible and collaborative approach
- Complex and multi-step synthesis
- Extensive validation experience
- Strength of process chemistry
Did you know?
Axplora is honored to be a recipient of 2023 CDMO Leadership Awards in 4 categories:
We also achieved Champion status in Expertise and Service:
Our API manufacturing services
Keeping your clinical program on-track requires an experienced Project Manager coupled with expertise and specialist capabilities.
Axplora 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:
- Process development:
- Process development & scale-up
- Analytical methods development, optimization, and validation
- Process validation
- Technical transfer
- Safety assessment
- Regulatory support
- ICH stability studies
- Manufacturing:
- Kg-lab, pilot, and manufacturing scale
- A wide range of flexible reactor trains from 30L to 12.5m³
- Clean rooms class 100’000
- 9 API manufacturing sites inspected by the FDA & EU authorities
- Clinical & commercial manufacturing
- Continuous improvement
As you work to bring your product to market, we aim at continuously streamlining and optimizing your API 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.
Supporting technologies for custom API manufacturing
Manufacturing your API with us also means leveraging advanced technologies such as:
- Hazardous chemistry
- Preparative chromatography
- Low-temperature chemistry
We are also a reliable and experienced manufacturing partner for Palladium cross-coupling reactions such as Buchwald, Cyanation, Heck, Sonogashira & Suzuki, … and many others reactions.
Our 9 API cGMP manufacturing sites
Located in Europe and in India, all of our 9 production sites are experienced with API manufacturing. The power of Axplora’s network lies in its ability to manage several steps of chemistry through different sites to provide flexible capacity and increase the security of supply.
| Sites | Process development | Pilot manufacturing | cGMP manufacturing |
| Chasse-sur-Rhône, FR | X | X | X |
| Chennai, IN | X | x | |
| Gropello Cairoli, IT | X | X | X |
| Le Mans, FR | X | X | X |
| Leverkusen, DE | X | X | X |
| Mourenx, FR | X | X | X |
| Pompey, FR | X | X | X |
| Raubling, DE | X | X | X |
| Vizag, IN | X | X | X |
Capabilities for the manufacture of your API
Our manufacturing plants offer a combined reactor capacity of over 600m3 with a wide range of equipment trains.
Our facilities enable us to offer a multi-site strategy to best accommodate our customers’ needs, leveraging our core technologies. For example, Axplora is highly experienced in combining synthesis & preparative chromatography and has access to one of the largest chromatographic purification platforms worldwide.
Discover why Axplora is a first-choice CDMO partner for your API manufacturing:
Our latest investments
Axplora has deployed an investment strategy for many years, investing continuously to upgrade its capacities and broaden the flexibility and productivity to satisfy its clients & their patients.
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- Create a new pilot workshop for API manufacturing focused on handling innovative and highly active products
- Investment supported by ‘France Relance’
- Announced in July 2022
- Mourenx, France
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- Debottlenecking of drying and purification capacities, and addition of a cleanroom
- Investment supported by ‘France Relance’
- Announced in December 2021
- Chasse-sur-Rhône, France
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- Increase flexibility and competitiveness
- Investment supported by ‘France Relance’
- Announced in June 2021
- Mourenx, France
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- Support growing demand for clinical and commercial supply of ADCs & HPAPIs
- Announced in May 2021
- Le Mans, France
Do you have an API in early phase development? Axplora provides services along your API journey, starting from your early phase needs!