CORDENPHARMA BERGAMO (IT)
- >> cGMP custom synthesis from lab to multi-tonne scale
- >> Multi-step API process development, manufacturing & analytical development
- >> Industrialization from feasibility to commercial scale
- >> Regulatory filing in the US, EU & Japan
- >> Inspected by Italian Medicines Agency (AIFA) and Italian Ministry of Health (Department of Veterinary products)
- >> Registered in the EUDRAGMDP database according to EU Directive 62/2011
- >> Relevant GMP Certificates are available on EUDRAGMDP database
- >> Inspected by US-FDA since the ‘80s (FEI 3002806963) and accredited in Japan (AG22000062 on 7th June 2017)
- >> Certified ISO 9001: 2008
- >> The QMS assures compliance to cGMP – as per EU GMP, Part II and ICH Q7, and to ISO 9001 requirements - it is managed by the internal Quality Unit, composed of Quality Assurance, Quality Control and IT Management & Compliance Units
- >> According to Italian law 219/2006, batch release is performed by Qualified Person
- >> CordenPharma Bergamo Inspections
CordenPharma Bergamo Environment Health Safety (EHS)
Corden Pharma Bergamo pays great attention to environmental and industrial safety, including employing advanced techniques in order to comply with national legislation and environmental regulation (D. Lgs. N° 152 April 3th 2006 e s.m.i.), and it has achieved OH SAS 18001 certification (Occupational Health and Safety Assessment Series) since 2013.
- >> The Waste Water Biological Treatment plant has been in operation since January 1992, and has a capacity of about 5 tons / day of COD (Chemical Oxygen Demand)
- >> The incinerator has been operating since 1990, and is able to incinerate about 60 tons / day of waste streams
- >> A fire prevention network serves all the installed reactors, operating with water and extinguishing foam sprayed at 7 bars of pressure, guaranteed by 2 independent pumps
Health & Safety Training
Corden Pharma Bergamo staff participate in health monitoring and training programs which are organized as required by current legislation (Italian law D. Lgs n°81 April 9th 2008 e s.m.i.; D. Lgs. n°105 June 26th 2015). Training courses for the technicians operating in the plants are regularly organized.
CordenPharma Bergamo is a cGMP manufacturer of advanced pharmaceutical intermediates and APIs specializing in the design of synthetic routes and development processes for new products from laboratory to commercial scale, with equipment and chemical technologies that are particularly suitable for multi-step synthesis.
CordenPharma Bergamo brings over 50 years of experience and expertise in pharmaceutical chemistry, technology, project management and registration processes to CordenPharma’s full-service CDMO platform.
- >> 1962 Started by a private owner
- >> 1979 First FDA Inspection
- >> 1989 Facility purchased by Tessenderlo Group
- >> 2012 Farchemia acquired by ICIG
- >> 2016 Name changed to Corden Pharma Bergamo S.p.A.