Locations in Europe
Our API manufacturing sites in Europe
With a wide network of eight sites across Europe, in France, Germany, and Italy, Axplora offers best-in-class CDMO services for APIs and advanced intermediates from process development to clinical and commercial manufacturing. In addition, we develop, scale up, and manufacture commercial APIs and advanced intermediates for the generic and originator pharmaceutical industry.
Chasse-sur-Rhône site
- Novasep CDMO plant
- Process development, scale-up, and manufacturing
- Expertise in combining organic chemistry with advanced purification technologies
Located near Lyon (France), our Chasse-sur-Rhône site offers CDMO services for APIs from clinical supply to commercial manufacturing. The site has an outstanding regulatory track record and offers industrial chromatography, low-temperature reactions, high-pressure hydrogenation, and an extensive toolbox of classical technologies.
Gropello Cairoli site
- Farmabios Plant
- Process development, scale-up, and manufacturing
- Specialized in steroids and HPAPI synthesis
- Solid state expertise
- Strong regulatory history
- EcoVadis 2023 GOLD-certified
Founded in 1961 and located near Milan (Italy), Gropello Cairoli’s site comprises a team of over 200 employees. It is a world leader in steroid chemistry, producing over 80 APIs and advanced intermediates such as Corticosteroids & Hormones (sterile & non-sterile). It also provides great expertise in the scale-up and production of HPAPIs, including cytotoxic and cannabidiol (CBD). The site offers CDMO services and is home to Axplora’s center of excellence in solid state chemistry.
Leverkusen site
- Novasep CDMO plant
- Process development, scale-up, and manufacturing
- Expertise in hazardous chemistry
Our custom manufacturing site in Leverkusen, located near Cologne in Germany, was founded more than 150 years ago and is Axplora’s center of excellence for hazardous chemistry. This site is a world leader in providing CDMO services for API, advanced intermediates, and fine and agro-chemicals from development to multi-ton scale, using an unparalleled range of energetic reactions such as azide, carbon disulfide, hydrazine chemistries, carbonylation, 02 oxidation, etc, and reactions involving hazardous reagents such as sodium cyanide. It is also a major producer of nitroglycerin-based APIs, supplied in various formulations for the generic market.
Latest inspections:
- National Health Authorities (Manufacturing permit and GMP certificate): 2023
- US FDA: 2018
- PMDA:
- ISO9001 and ISO50001: 2021
Le Mans site
- Novasep CDMO plant
- Process development, scale-up, and manufacturing
- ADC manufacturing: payloads, payload-linkers, ADC conjugation, and ADC drug product release testing
Conveniently located one hour from Paris by high-speed train, our Le Mans custom manufacturing site benefits from more than thirty years of experience in HPAPIs and industrial chromatography . The site offers full CDMO services to pharmaceutical innovators for process development, scale-up, and commercial production of ADCs. A state-of-the-art facility, the site provides a full and flexible range of ADC manufacturing services, with hands-on experience on most payload-linker and conjugation platforms.
Mourenx site
- Novasep CDMO plant
- Process development and large-scale manufacturing
- Large-scale continuous chromatography
- Purification of omega-3
Located near Pau (southwest of France), our Mourenx site has over forty years of CDMO experience in large-scale API manufacturing & benefits from an excellent regulatory track record. The site houses the world’s largest continuous industrial chromatography facilities equipped with total solvent recycling for the multi-ton production of ultra-purified omega-3 APIs such as Icosapent ethyl.
Pompey site
- Novasep CDMO plant
- Process development, scale-up, and manufacturing
- The most versatile contract purification platform in the world for biologics and small molecules
- Best-in-class expertise in purification including chromatography
Located near Nancy (France), this site is Axplora’s center of excellence for chromatography. The site has more than 25 years of experience in CDMO services involving industrial chromatography for the purification of APIs, cGMP intermediates and biomolecules from process development to commercial supply. Key technologies include large-scale HPLC, continuous chromatography (SMB), low-pressure chromatography, process simulation, and membrane filtration (UF/DF, nanofiltration).
Headquarters and manufacturing site in Raubling
- PharmaZell Plant
- Axplora Group Headquarters
- Electrochemistry and enzymatic reactions
- EcoVadis 2023 SILVER certified
- Five production units on a commercial scale
- Seven production lines
- One pilot plant according to cGMP standard
- Laboratories for customised development and analysis
- Small scale laboratory according to cGMP standard
The Raubling site near Munich (Germany) is home to Axplora’s headquarters and a production facility for generic APIs and CDMO services. It was founded in 1946 with a generic pharmaceutical focus on different therapeutic areas such as anti-inflammatory, gastrointestinal, mucolytic, and anti-arrhythmic. Over 150 employees are involved in the development, scale-up, and manufacture of APIs with customized particle sizes and physical properties. The site has a unique expertise in operating electrochemistry and enzymatic reactions at multi-ton scale.
Most recent inspections and audits:
- Government of Upper Bavaria, competent authority (Germany), regular, 2022
- FDA (US), regular, 2022
- PMDA (JP), 2016
- Regular customer audits
Management Center in Lyon
- Novasep CDMO center
- Support Functions
In addition to our API sites, we have a Management Center in Lyon. It hosts members of Axplora’s Executive Committee, as well as the communication, finance, and legal departments. It brings together a team fully committed to supporting the whole Axplora group.
