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PROCOS S.p.A., a fully owned subsidiary of the Japanese CBC Co. Ltd Group, focuses on the development, scale-up, and manufacturing of Active Pharmaceutical Ingredients (APIs), advanced intermediates, and associated services for the pharmaceutical sector.
Description
PROCOS S.P.A. is a CDMO established in 1945, is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPI), linker-payloads, advanced intermediates, and related services for the pharmaceutical industry. Located in Cameri, Italy, PROCOS size 155,000 sq. meter of cutting-edge multipurpose plant, fully designed under cGMP compliance, with 560 m3 of reactor capacity. The site fully is audited and approved by the main regulatory authorities including AIFA, FDA and PMDA. PROCOS provides 360° support to Customers, providing the most advanced techniques (like flow chemistry, QbD, Automation, Tides….) to ensure successful development and supply of their API from preclinical to commercial through all the phases. The continued expansion of the site shows a deep commitment to innovation and technological advancement for PROCOS and its network of global customers.
Type of Drugs Manufactured:
Small Molecule
CDMO Services:
Drug Substance Manufacturing (API);Research & Development;Regulatory Services;Analytical Development
Number of Manufacturing Facilities:
1
High Potent Products capabilities:
OEB 3;OEB 4-5;OEB >5
Facilities Locations:
Europe
Regulatory Approvals for facilities:
FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan)
Current Capacity:
- 560 m3 of reactor capacity
- HP and non HP down to 1ng/m3
- R&D development and non GMP manufacturing of tides up to multigram scale
- Support from pre-clinical to commercial supply
- HP and non HP down to 1ng/m3
- R&D development and non GMP manufacturing of tides up to multigram scale
- Support from pre-clinical to commercial supply
Certification
United States FDA, GMP, Europe EMA, ISO, Japan PMDA, Canada Health Canada, Italy AIFA, ISO 14001, ISO 45001, CYBERVADIS
Manufacturing Information
Facilities
1
Drug Type
Small Molecule
Capabilities
Contact Information
Website
Phone
Address
Via Giacomo Matteotti, 249, 28062, Cameri (Novara), Italy
Zip/Post Code
28062
Facility Locations
Italy
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