Profile

Pure Chem offers manufacturing capability on a variety of scales across the grams to kilos to tones range. Our plant consists of most modern equipment and machineries for manufacturing APIs and intermediates as per cGMP norms and back supported by documentation as per ISO 9001:2008 certifications. Well-trained workmen under the supervision of experienced professionals handle complex molecular synthesis with accomplished ease to deliver products of high quality. Processes are developed following the Indian, US, European, Japan Pharmacopeial Standards. All our operations are carried out as per cGMP norms, Good Laboratories Practices (GLP) norms, Validated Systems and Standard Operating Procedures.

Major manufacturing activities include:
  • Active pharmaceutical ingredients (APIs) and intermediates manufacturing.
  • Contract Manufacturing
  • Scale up studies for any given process
  • Process Optimization.
  • Scale-up production from a few kgs to tons
  • Regulatory documentation, including DMFs (CTD format)
  • Custom synthesis and process development in lab to establish proof of concept

Manufacturing Facilities

  • SSR Reactors
  • GLR Reactors
  • Dryers
  • Vacuum system
  • Micronisation
  • Gas Absorbers
  • Reaction range
  • Small Scale
  • Capacities from 0.2KL to 5KL
  • Capacities from 0.2KL to 4KL
  • (1) Rotary vacuum, (2) Fluidized bed, (3) Tray Dryer, (4) Vaccum tray dryers
  • (1) Ventrui Pump, (2) High vacuum Pump
  • (1) Multi-mill, (2) Miller-Shifter
  • High Efficiency Scrubing system
  • -10ºC to 150ºC
  • State of art Pilot plant, R&D Lab

Analytical Capability

  • Chromatography
  • Spectrophotometry
  • Titrimetry
  • Polarimetry
  • Physical testing
  • Stability studies
  • Balance
  • Water system
  • HPLC, GC
  • UV/Visible
  • (1) Autotitrators (2) Potentiometers (3) Karlficher apparatus
  • Variable Wavelength Polarimeter
  • (1) Melting Point Apparatus (2) Bulk Density Testing, LOD (IR)
  • Environmental Testing Chambers
  • Analytical Micro Balances
  • (1) DM Water Plant (2) RO System

Reaction Capabilities

  • Amidation
  • Bromination
  • Chlorination
  • Friedel-Crafts reaction
  • Grignard reaction
  • Nitration
  • Sulphonation
  • Esterification