Chemical development

Syngene provides comprehensive Process Research & Development (PRD) and Current Good Manufacturing Practices (cGMP) manufacturing capacities to investigational and commercial programs. Our core competency is to resolve complex scientific problems with a systematic approach in time-bound manner.

Syngene’s chemical development team (900+) consists of experienced process chemists, process engineers, analytical scientists, safety professionals, and manufacturing experts with an unparalleled track record. The Chemical Development team is ably supported by an expert team of the supply chain, warehouse, quality control, and quality assurance personnel. The team is proficient in developing robust chemical processes and scale up the product of interest rapidly. Our assurance to customers is – Quality, On Time and In Full, of processes and products. We cater to various industries such as Pharmaceutical, Specialty chemicals, Agrochemicals, Polymers, Oligonucleotides, Animal Health, and Consumer products. Depending on the end application, the manufacturing is done in an appropriate facility at Syngene.

Our scientists have significant training and experience in varied Chemistry and engineering capabilities viz. synthetic organic chemistry, analytical chemistry, process chemistry, process safety, and engineering. Syngene scientists, while working on client projects have contributed intellectually towards chemistry problems and have been named as co-inventors, providing a strong testament to our ability to add value to the partner’s programs. We have a strong pipeline of experienced personnel who can be assigned to the projects promptly.

Our facilities have been inspected by regulatory authorities (Indian and International), certifying agencies such as US FDA, EMA, PMDA, etc, qualified persons, client QA and third-party auditors. Our dedicated cGMP facility is certified by DCGI as well as by independent certifying agencies like TUV Nord.

Key differentiators:

  • 125+ fume hoods in multiple suites
  • Automated lab scale jacketed reactors (-70 to 180 °c)
  • OEL- micro gram 0.1 μg/m³ – 8h
  • Flow Chemistry
  • Dedicated process engineering and safety lab
  • HPAPI development – from Lab to Manufacturing scale
  • Therapeutic and Diagnostic Oligonucleotide – from Lab to Manufacturing scale
  • Performance and Speciality Materials – synthetic organic chemistry, polymer chemistry and scale-up activities
  • Integrated analytical services- analytical method development, validation, transfer and reference standard qualification
  • Regulatory Support