Clearsynth is one of the global leaders in synthesis and supply of isotope labelled research chemicals. Sakshi Sharma, Market Research Analyst, Clearsynth, reveals more about the company, in discussion with Sachin Jagdale
Describe your services for the pharma industry?
Clearsynth is a technology-based, 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?
There has been a paradigm shift in the pharma industry. Currently, quality of products is given utmost importance by all regulatory bodies. The consumer demands perfection in quality, reliability, low cost and timely performance. There has been considerable increase in demand for sustainability in manufacturing as well.
Give details of your Hyderabad and Canada plants (products, capacity, staff, market they serve etc)?
Our state-of-the-art R&D centres are located in Hyderabad, India and Mississauga, Canada.
R&D Lab – Hyderabad Hyderabad: 100,000 sq ft
The cGMP compliant R&D facility based at Hyderabad is operational since 2010. The site has its expertise in synthetic organic chemistry, offering custom synthesis services scaling from milligrams to kilograms, with over 200 chemical fume hoods. The lab is also open to take up contractual research projects, analytical services and FTE. All chemistry activities at Clearsynth are directed and led by Ph.D level organic scientist with combined 22+ years of experience in the pharma and biotechnology industry. The facility is well equipped with modern analytical instruments (NMR, GC, LC MSMS, IR/UV, TGA, DSC, Prep HPLC, flash chromatography) and is accredited with ISO 9001: 2008 (Quality Management System), ISO 14001 : 2004 (Environmental Management System) and OHSAS 18001: 2007 (Health & Safety Management System) standards.
R&D Lab, Suite 1001 – Mississauga, Canada Canada: 8,000 sq ft
Clearsynth has newly expanded its R&D capabilities at Mississauga, Canada to serve the North American markets. The new state-of-the-art R&D centre is in the forefront of Clearsynth’s efforts for a successful entry into advanced regulated markets. Clearsynth Canada is expected to strengthen our core business in custom and contract organic synthesis, mall and large molecule manufacturing, process development and undertake complex synthesis projects.
Clearsynth Canada is well equipped with modern analytical instruments and is expected to take up research assignments in the areas of contract research and manufacturing services.
Who are your pharma clients?
Presently, Clearsynth is serving over 3000 clients across 58 countries. Our major clients are Roche Diagnostics, Agilent Technologies (Instrumentation), Defence Research Organisation, Eurofins (Analytical), Anapharm, Glaskosmithkline (Drug Discovery), Teva (Active Pharma Ingredients), Syngenta Crop Protection Munchwilen AG (Agrochemicals), and pharmacopeial institutes
Besides pharma, which are the other industries you cater to?
Clearsynth offers its services to a broad spectrum of industries such as clinical research organisations, universities, research institutes, veterinary sciences, testing labs, forensics, agriculture, material sciences, defense, geology, hydrology, archaeology, microchips, semiconductor and others.
What percentage of your revenue comes from the pharma industry?
More than 70 per cent.
What is your market share in India as far as pharma business is concerned?
Approximately 70 per cent.
Since chemicals are major environment pollutants, what are your efforts to develop environment friendly processes and products?
All our products are developed through various treatment plant such as effluent plant. All the effluents are treated in our sewage treatment plant before disposal thereby ensuring we cause no harm to the environment. Clearsynth R&D facilities is accredited to Environmental Management System Certification ISO 14001-2004 which assures company to fall in line with significant environmental aspects.
What are your future plans?
Clearsynth intends to be the catalyst in accelerated discovery via synthesis of complex and difficult to make compounds. It aims to be the global leader in synthesis and supply of isotope labelled research chemicals. The company is also expanding its footprints in markets beyond North America and Europe.