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By PharmaCompass
2022-05-30
Impressions: 6069
View EUROAPI's portfolio of APIs like small molecules, peptides, steroids, opiates & controlled substances & browse its CDMO services on PharmaCompass
Q1. What is EUROAPI and what are the different CDMO services it offers?
With over 200 products in its portfolio, EUROAPI is a world leader in active pharmaceutical ingredients (APIs). It offers a wide range of technologies, while developing innovative molecules through its contract development and manufacturing organization (CDMO). It is the market leader in small molecules API, with a unique European industrial platform and a proven track record for reliability.
Based on Sanofi’s 15 years of experience in the field of oligonucleotides and 45 years in the field of peptides, EUROAPI offers a unique state-of-the-art platform for their development and scale-up at Hoechst Industrial Park in Frankfurt (Germany). EUROAPI covers both API solutions as well as contract development and manufacturing organization (CDMO) services.
It has expertise in quality, regulatory and supply, and has dedicated commercial teams for its clients all around the globe. For its global healthcare partners, it develops, manufactures and supplies active pharmaceutical ingredients. Its Frankfurt facility is a pioneer in solid-phase synthesis. It is regularly inspected by the FDA, along with other European and international agencies.
Various CDMO Services offered by EUROAPI are noted below:
Small molecule synthesis
EUROAPI has developed a unique heritage in API development and organic synthesis by combining the chemical expertise of Hoechst-Aventis, Roussel-Uclaf, Chinoin, Genzyme and Sanofi. EUROAPI offers a full CMC service for drug substances to support clinical development to registration and commercial delivery. Its six commercial facilities employ over 250 scientists and provide 2,000 m³ cGMP for organic synthesis and 6,000 m³ for microbial fermentation to produce small molecules. It has an experienced R&D team with proven experience on multi-ton small molecule APIs and intermediates.
Microbial Fermentation
EUROAPI is a leading global provider of high-quality custom microbial process development and manufacturing for pharma companies. From proteins and enzymes to yeasts and actinomycetes, its expertise spans a spectrum of GMO and non-GMO microorganisms procured in its 6,000 m³ microbial fermentation capacity at its facilities in France and Italy. EUROAPI has more than 20 multipurpose fermenters with a total capacity of 2,000+ m³which offers pilot and industrial-scale fermentation, from 1 m³ to 120 m³.
Particle Engineering
EUROAPI is an expert in particle engineering, with expertise in two key technologies: micronization (for development and commercial-scale operations, inhalables and nanoparticles) and spray drying (for development to commercial-scale output). The EUROAPI Vertolaye plant in France is its center of excellence for particle engineering - micronization.
Spray Drying
In the food and pharmaceutical industries, the spray drying method has developed over the last 30-50 years. Spray drying increases a product’s solubility, bioavailability and flow characteristics.
With over 20 years of experience in commercial pharma spray drying, the EUROAPI Haverhill plant in the UK has emerged as a center of excellence for spray drying. EUROAPI has pre-clinical, clinical and commercial spray-drying capabilities, so it can handle both small and large-scale spray drying projects. All spray dryers can handle solutions, suspensions and emulsions.
Tides CDMO Services
EUROAPI provides development and scale-up services based on Sanofi’s 15 years of experience in the field of oligonucleotides and 45 years in the field of peptides. EUROAPI is responsible for a wide range of development activities, from the clinical development phase to submission and launch, including regulatory support and commercial supply.
EUROAPI has over 45 years of experience in peptide development, from lab to cGMP production. It can provide a full development pipeline for peptide synthesis, including semi-automated solvent supply and waste management.
Prostaglandins Development and Manufacturing Services
EUROAPI is a leading global supplier of prostaglandins, which are naturally produced, versatile biochemicals used to fine-tune a variety of physiological reactions. With over 15 prostaglandin APIs in its portfolio, EUROAPI provides comprehensive R&D and fully integrated cGMP manufacturing from a continuous improvement perspective.
Steroid and Hormone CDMO Services
Since its inception about a century ago, steroid and hormone manufacturing has been a core activity at EUROAPI. Today, it produces more than 20 active pharmaceutical ingredients (APIs) with a steroid skeleton via complex chemical routes. It has over 100 scientists dedicated to small molecule synthesis and steroid development. Its site in Vertolaye, France, has a 700-strong workforce who are experts in corticosteroids.
Opiates & Controlled Substances CDMO Services
From poppy-seed harvesting to API manufacturing to new controlled substance development, EUROAPI provides comprehensive synthetic chemistry expertise to address technically and financially complex requirements, from development to commercial production.
EUROAPI, through Francopia, acts as a manufacturer/distributor for its entire opiate and opioid API portfolio. These drugs are made at a Sanofi-dedicated site using a continuous extraction process. The company also offers controlled substance development and manufacturing as well as intermediates for controlled substance APIs and hemi-synthesis.
Q2. Where are EUROAPI’s manufacturing sites located and what are their certifications?
EUROAPI encompasses the entire range of development activities, from the clinical development phase to submission and launch, along with regulatory support and commercial production.
EUROAPI’s manufacturing sites and certifications are noted below:
Haverhill, U.K. - This facility offers contract development & manufacturing organization (CDMO) activity & APIs.
Key technologies & capabilities - Spray-drying across all scales & process analytical technology (PAT), flow chemistry
Certifications - FDA, ANVISA, PMDA, MHRA, CFDA
Saint-Aubin-lès-Elbeuf France - This manufacturing site offers Biochemistry APIs.
Key technologies & capabilities - Large-scale fermentation and downstream processing
Certifications - FDA, ANSM, FAMI-QS, DDPP, Halal, Kosher and ISO50001 certification
Vertolaye, France - This multipurpose chemical plant is the API production & solid development center of EUROAPI
Key technologies & capabilities - GMP micronization (including cryomilling) and Organic synthesis (large-volume corticosteroids & hormones), including high potency products (OEB5), etc.
Certifications - FDA, ANSM, PMDA, KFDA and ISO14001 certification
Frankfurt, Germany - This is a multipurpose chemical site for API Production & Development (Chemistry+Tides).
Key technologies & capabilities - Solid phase chemistry for peptides & oligonucleotides and organic synthesis (large-volume), along with GMP micronization (including cryomilling) and flow chemistry.
Certifications - FDA, EMA, PMDA
Ujpest, Hungary - This site is EUROAPI’s API production & development center (chemistry).
Key technologies & capabilities - Multipurpose chemical site, development center from kilo-lab to large pilot, prostaglandins and high potency products (OEB5), industrial-scale production (200 kg – 200 MT), intermediates, hazardous (toxic, unstable) reaction, hydrogenation
Certifications - FDA, OGYEI, PMDA
Brindisi, Italy - This facility is the biochemistry API & development center of EUROAPI.
Key technologies & capabilities - GMP biochemistry, large-scale fermentation and downstream processing
Certifications - FDA, AIFA, Korean FDA, ANVISA, PMDA
Q3. What are the different active pharmaceutical ingredients (APIs) offered by EUROAPI?
EUROAPI is a world leader in active pharmaceutical ingredients (APIs) with some 200 products in its portfolio. Various types of APIs offered by EUROAPI are noted below:
Vitamin B12 - Being the only western manufacturer of vitamin B12, EUROAPI plays a very important role in ensuring its global supply. Equipped with its decades of experience in biotech manufacturing, EUROAPI manufactures all of its vitamin B12 at the facility in St-Aubin-lès-Elbeuf, France.
Prostaglandins - EUROAPI is the owner of the world’s largest prostaglandin API production facility and is the world’s top supplier of prostaglandins for large-scale commercial pharmaceutical production.
With over 15 prostaglandin APIs in its portfolio, multiple patented processes and more than 100 clients globally, it provides comprehensive R&D and fully integrated cGMP manufacturing from a continuous improvement perspective.
Anti-infectives - From tuberculosis to meningitis to MRSA infections, anti-infectives are essential in treating a wide range of infections. EUROAPI’s renowned site in Brindisi, Italy, offers a comprehensive suite of anti-infective APIs. EUROAPI manufactures all of its anti-Infectives at the Brindisi facility.
Corticoids & Hormones - Corticoids and hormones are among the most versatile and commonly used active pharmaceutical ingredients today. Both of these API families have a wide range of applications in human and veterinary medicines. With over 70 years of expertise, EUROAPI has the largest corticoid portfolio in the market. It is the only European corticoid manufacturer with a fully integrated production process. The company has two R&D expertise units dedicated to small molecule synthesis and steroid development.
Small and Complex Molecules
From over-the-counter (OTC) analgesics to life-saving treatments for cardiovascular (CVS) diseases, small molecule synthesis is critical to the development and effectiveness of a wide range of pharmaceutical medications. EUROAPI’s current synthesis portfolio has about 60 small molecule API references spanning a highly diverse range of therapeutic uses for both humans and animals.
Opiates & Controlled Substances - EUROAPI manages the seed-to-shelf production of an expanding portfolio of opiates, such as morphine, codeine and thebaine. It also supplies molecules from the “Nals” family, such as naloxone, naltrexone and nalbuphine, as well as anti-addiction and pain medications, along with apomorphine.
Q4. What are the environmental sustainability initiatives undertaken by EUROAPI?
EUROAPI has proposed innovative processes and services for environmental sustainability.
EUROAPI’s Priorities:
- Promote the highest quality of standard
- Improve its environmental footprint in order to meet all EU environmental goals, including climate mitigation and adaptation, water management, circular economy, pollution prevention and biodiversity
EUROAPI ensures a safe and fulfilling environment for all its employees. It
- promotes cultural diversity and international mobility
- commits all the employees to a zero-accident goal
- ensures all employees are uniquely valued and that they work in an inclusive environment.
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