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R/D & Manufacturing Partners

Best Chemical Company in New Jersey
  • non-GMP
  • >110 reactors
  • -78 oC to 250 oC capacity (1000 – 9000 L)
  • Organometallic chemistry
  • High pressure hydrogenation
  • Strong relationship with BI
  • CDA and BA signed
  • cGMP (FDA approved 3 times) and non-GMP
  • US trained managers from big pharmas
  • BI, Merck, Schering-Plough, MBS audited
  • CDA signed
  • non-GMP and cGMP
  • High pressure hydrogenators (up to 100atm)
  • Large photochemistry facility
  • Continuous, Flow-chemistry equipment

During the last 15 yrs, scaled-up >84 processes and delivered 5 to >800 kgs manufacturing partners, all successful!

cGMP Partner in US

aromatic chemistry definition
  • All analytical supports, stability study
  • Analytical method development
  • Chiral and achiral preparative HPLC isolation
  • Synthetic labs of cGMP, GLP and nonGMP for up to kg API production
  • Stability study
  • 3 cGMP campaigns with Primera, and no 483 issued. FDA audited 5 times without major issues.

cGMP Partner in US, Primera

cGMP Partner in US, Primera

aromatic chemistry definition

GLP

2015 2017

cGMP Partner in US, Primera

GMB

2008 2012 2015 2017 2018