Procos S.p.A. is an Italian Contract Research and Manufacturing Organization (CRO, CMO) specializes in development, scale-up and production of APIs and GMP advanced intermediates for the pharmaceutical industry.
Procos is an important member company in the international CBC Co. Group, headquartered in Japan. This network provides Procos with global reach, reinforced with its own subsidiary sales offices in the USA, Slovakia, Germany and India.
Over 70 years, Procos has built up a comprehensive range of technologies and capabilities to provide high quality products and services that have been widely accepted in worldwide pharmaceutical markets. It continuously develops and adds unique generic APIs and key intermediates to its product portfolio.
Custom synthesis and Generic API manufacturing is located in a 100,000 sq. meter flexible multipurpose cGMP plant that includes more than 300 cubic meters of capacity in stainless steel and glass lined reactors and is being expanded with a new 4000m2production area with 110 cubic meters of new additional production capacity.
Products and Services
Procos’ two core business sectors are the development and supply of APIs and GMP advanced intermediates along with contract manufacturing services.API manufacturing
Procos manufactures more than 30 products, mostly under uniquely designed synthetic methods and under strict regulatory compliance management. Procos-manufactured generic APIs cover all important therapeutic categories.Contract manufacturing services
Procos provides related services for the pharmaceutical industry acting as a CRO/CMO for custom synthesis on exclusive base, supporting customer from early clinical stage up to full -scale commercial production. This includes offering diversified technology and skills in sophisticated molecules development, optimization and production. Procos can also provide tailor-made proposals to meet specific customer needs.
Development services include IP analysis expertise and effective patent challenge skills.
Intellectual property rights (IP) on Procos-developed custom synthesis and manufacturing process is exclusively conferred on the customer.
Customer services include development, optimization and validation of analytical methods for API and advanced intermediates.
PROCOS can also advise on the optimization, scale-up and production of APIs and GMP advanced intermediates and has four different scale plants authorized for GMP production:
- Minilab (Laboratory scale)up to 100g
- Kilo lab from ~100g up to 5 Kg
- Pilot Plant from 5 Kg up to 70 Kg
- Industrial plant from 70 kg up to tonnes.
All four scales use the same proven and rigorous system to assure quality.
This Gantt chart details the process steps and timeline involved in a recent case study, showing progress from project start to industrial scale-up in only 18 weeks.
Procos is highly experiences in the manufacture of a wide range of products that incorporate uniquely designed synthetic methods and are produced under a strict regulatory compliance management regime.
Innovation is a driving force of Procos activity. The company’s products are based on patented technologies and cost-effective processes. Procos chemistry expertise is focused on the most complex organic reactions, including:
- Organo-metallic catalysis
- Multi-catalytic hydrogenation
- Enantioselective chemistry
- Hazardous Chemistry
Procos analytical technologies cover all the main methodologies for the development and full characterization of the API and advanced intermediates. These technologies include NMR, PXRD, LC-MS, GC-MS, UPLC, HPLC, GC, quantitative TLC, DSC, TGA, and PSD equipment.
Procos collaborates with academic institutes and key players in specific technologies to support a constantly innovative product pipeline.
Standards and Compliance
The state of the art Procos factory at Cameri has been fully designed for GMP compliance and follows a strict internal quality management policy.
Procos complies with all main international cGMP and regulatory guidelines, including US FDA, EMEA, PMDA and ICH/Q7A guidelines).
Procos production facilities are authorized and routinely inspected by the main regulatory bodies, including Italy’s AIFA, FDA, PMDA and has been awarded cGMP Certificate, as well as ISO 14001 Certification and OHSAS 18001.
The company maintains world-class facility standards, with finishing department comparable to the FDF pharmaceutical grade.QC and R&D labs are state-of-the-art in terms of equipment and instrumentation.
Procos has established a robust Quality System that is constantly assessed by international regulatory authorities. The system follows a “quality inbuilt” approach based on the lifecycle of the API, starting from the development phase.
Procos experience of regulatory processes is also used to support worldwide customers’ registrations.
To learn more about Procos products and services and how they can assist your business, please contact the supplier directly.
- > Procos launches high containment HPAPI oncology production to new plant
- > Procos brings synthesis expertise to scale up conference
- > Successful FDA & AIFA inspections for Procos cGMP production
- > Procos releases new brochure and APIs catalog
- > Procos high profile presence at Scale Up Conference
- > Procos underlines South Asian presence at CPhI India
- > Procos rolls out new look website
- > Procos fields expanded team for CPhI Worldwide
- > Calorimetric Studies in Early Stage of Chemical Process Development
- > Procos showcases new capabilities at CPhI China
- > Procos raises Eurasian profile at CPhI Istanbul
- > Procos unveils new manufacturing facility plans at CPhI Japan
- > Procos Institutional Company Brochure
- > Procos API List 2016
- CRO, CMO, CRAMS & CDMO
- Formulation & Ingredients
- Manufacturing & Production