Ennore

Our Ennore, India cGMP facility offers chemistry services that range from intermediate, RSM synthesis to development and supply of early phase API’s up to phase II. Ranging from Kilo lab to muti ton supply.

Location Address:

Piramal Pharma Limited, Ennore Express Highway, Ennore, Chennai – 600057 (India)

Contact: +91 4442987900

Specialized Capabilities

  • State-of-the-art cGMP Kilo-lab capable of manufacturing 0.5 to 15 kg batches of NCE for clinical supplies
  • Multi-purpose pilot plant (2–20kg) and commercial facilities capable of manufacturing up to 200 tons per annum (GMP as well as non-GMP), and handle reactions from -80°C to 250°C
  • Complex reactions (e.g., Cyanation, hydrogenation, ozonolysis, organometallic coupling, nitration, and asymmetric synthesis) carried out at commercial scale
  • Strong technology transfer team which undertakes process from R&D to manufacturing facility with ‘First Time Right’ approach
  • Fully equipped synthetic and analytical labs backed by advanced instruments such as HPLCs equipped with PDA, UV, ELSD detectors, GC – Direct & Headspace, Semi preparative HPLC, Mass spectrometers (GC –MS, LC mass systems [Ion trap]), 400 MHz Bruker NMR, DSC, FTIR, UV and Polarimeter

Featured Services

  • Route design and process development services 
  • Phase appropriate analytical method development and validation
  • Synthesis of analogs, reference standards, impurities, impurity isolation, and characterization
  • Process validation and stability studies
  • Manufacture of NCEs up to Phase IIA supply (cGMP)
  • Starting material, key starting material registered starting material and intermediate supply up to commercial scale for regulated markets

Salient Features

  • Synthetic labs with 60 fume hoods
  • Advanced flow reactor capability
  • Process safety and intensification lab
  • Seamless on-site process development and manufacturing
  • ISO 9001, ISO 14001, ISO27001, and OSHAS 18001 certified
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