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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

  • 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

GLP

2015 2017

cGMP Partner in US, Primera

GMB

2008 2012 2015 2017 2018