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:

Axplora CDMO leadership awards 2023

We also achieved Champion status in Expertise and Service:

Axplora CDMO leadership awards champion 2023

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.

Axplora API manufacturing

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:

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.

Axplora API manufacturing reactors

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.

SitesProcess developmentPilot manufacturingcGMP manufacturing
Chasse-sur-Rhône, FRXXX
Chennai, INXx
Gropello Cairoli, ITXXX
Le Mans, FRXXX
Leverkusen, DEXXX
Mourenx, FRXXX
Pompey, FRXXX
Raubling, DEXXX
Vizag, INXXX
Axplora API manufacturing capabilities

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.

Axplora CDMO services for Pharmaceuticals

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.

Do you have an API in early phase development? Axplora provides services along your API journey, starting from your early phase needs!