Clearsynth Intends to Be the Catalyst in Accelerated Discovery

- Sachin Jagdale

Describe your services for the pharma industry ?

Clearsynth is a technologybased, research-driven organisation that specialises in developing certified analytical standards and high-end isotope research chemicals. The company is engaged in synthesis for stable, isotope-labelled compounds, metabolites, impurities, glucuronides, chiral compounds, conjugate impurities and radioactive labelled compounds. It is one of the few companies in India which deals with stable isotopes labelled compounds such as carbon-13, deuterium, nitrogen-15 and oxygen-18. The company is involved in supplying complex internal standards for mass spectroscopy LCMS use. Clearsynth specialises in custom synthesis of reference standards, complex and ‘difficult to synthesise’, chemicals which are in compliance with global regulatory standards and high purity. At present, we are the world's largest inventory of deuterium compounds with around 2800+ internal standards and supplying it worldwide for LCMS use in PKPD studies.

Which are the challenges you face while dealing with the pharma sector?

Well, as pharma innovation is at peak, quality for products has become a major concern. Consumers are becoming more aware for the significance of quality of the products. For every product we deliver, there is a demand for certificate of analysis and quality reports along with it. Meanwhile, stringent FDA policies, regular audits at facilities and full adherence to GMP guidelines are major requirements that the company has to deal with.

How have pharma requirements changed over the years?