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 ISO 45001 certified