"Clearsynth adheres to the changing requirements by introducing advanced mechanisms and instruments"

Vijay Ambati,
President & CEO,
Clearsynth
Clearsynth intends to be the catalyst in accelerated discovery via synthesis of complex and difficult to make compounds. The company is dedicatedly developing future molecules to meet the requirements of pharmaceutical industry and targeting new sectors such as enzymes, natural extracts, vitamins, hormones and petrochemicals.” Says Vijay Ambati, President & CEO, Clearsynth. Excerpts from the interview he had with Mahesh Kallayil.

Could you please tell us about Clearsynth's offering to Pharmaceutical industry?

Clearsynth is a technology based research driven enterprise, with World's Largest Inventory of Reference Standards & Research Chemicals. The company specializes in manufacturing of pharmaceutical chemicals like Stable Isotope Labelled Compounds, Metabolites, Conjugate Impurities & Innovative Organo-chemistry, custom synthesis of Complex Glucuronides. It is one of the leading companies which is developing chemicals using stable isotopes labeled compounds such as deuterium, oxygen-18 and others.

The Company involves in supplying complex internal standards for Mass spectroscopy LCMS use. The research chemicals are in compliance with global regulatory standards and high purity.

How are you currently placed in Global as well as Indian market?

Headquartered in Mumbai, India the company has state of the art research and development centers in Hyderabad, India and Mississauga, Canada. The R&D centers are well equipped with advanced equipments. 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 mg to kg with over 200 chemical fume hoods Also, newly expanded R&D facility at Canada is fulifilling the requirements of North American markets. This center is in the forefront of Clearsynth efforts for a successful entry into the advanced regulated markets. 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. The company is catering to 60 countries, across five continents serving 5000+ clientele. Our major clients are Roche Diagnostics, Agilent Technologies (Instrumentation), Defence Research organization, Eurofins(Analytical), Anapharm, Glaskosmithkline (Drug Discovery), Teva (Active PharmaIngredients), Syngenta Crop protection Munchwilen AG (Agrochemicals), and Pharmacopeial institutes.

Please apprise us your complete product portfolio/services provided by you and the market opportunities of these products/services in India and abroad?

Clearsynth supplies Certified Analytical Standards and High End Isotope Research Chemicals of high purity. It is engaged in Custom synthesis of Reference standards, complex & "difficult to synthesize" chemicals which are in compliance with global regulatory standards and high purity. Major product portfolio comprises of API standards, stable isotopes, metabolites, impurities, glucurondes, deuterated solvents & reagents and chiral standards. Some of the other target compounds are intermediates, fine chemicals, phytochemicals, catalysts, inhibitors, peptides, NMR solvents and others.

Approximately 70 per cent of our revenues come from the pharma companies as the products we deliver help in quantitative analysis of medicines and biological molecules. Apart from pharma, clinical research organizations, Universities, Research Institutes, Veterinary Sciences, Testing Labs, forensics, Agriculture, Material Sciences, Defense, Geology, Hydrology, Archaeology, microchips, and semiconductor manufacturers are using our products.

What are the initiatives that you are undertaking currently to sustain the frontier position you have in the market?

For every product we deliver we ensure that it is supplied with certificate of analysis and other quality reports. With the pharma innovation at its peak, and rising consumers awareness, quality and sustainability is our primary goal. Further affordable cost, faster delivery, and meeting clients orders on time is what we aim for. All our products are developed through treatment plant such as effluent Plant. 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.

How do you evolve the research and development to keep a pace with the changing dynamics of market?

Clearsynth adheres to the changing requirements by introducing advanced mechanisms and instruments. Recently the company has established High-Field Bio- -NMR/ 600 MHz facility at its R&D LAB in Hyderabad. The advanced facility will give scientists an easier and quicker way of quantitative analysis like never before. The spectrometer is ideally suited for solution-state NMR studies on biological macromolecules like proteins and nucleic acids.

Kindly appraise us on your recent collaborations. How you think these deals going to help Clearsynth to strengthen its market presence?

Clearsynth is partnering with world's strongest R&D companies such as GSK, Teva pharmaceuticals, Lupin Pharma, Dr. Reddys Laboratories to supply them with innovative molecules on timely basis. Client satisfaction is our utmost priority. The company is meeting their requirements for complex impurities, analytical standards and future molecules. The high purity chemicals supplied by Clearsynth support advance research and quantitative analysis. Partnership with global giants motivates us to deliver better with each order.

What kind of structural change you envisage for the Indian pharmaceutical industry, as the biosimilar and generics are likely to play a dominant role now?
India has an immense capability of becoming manufacturing hub in coming years. Indian companies are among the world leaders in the production of generics and vaccines. Both of these areas are becoming more important following accelerating chronic diseases such as Malaria, dangue, HIV and cancer. India's epidemiological profile is also changing, so demand is increasing for drugs of cardio-vascular problems, disorders of the central nervous system and other chronic diseases.

The R&D pioneers Lupin, Sun Pharma, Cipla, Zydus are conducting intensive research and partnering with global pharma companies to market their drugs outside of India. India is also the potential place for conducting clinical trials much more cost effectively than in many developed nations. By government's initiatives like new patent regimes which might provide better protection of intellectual property rights, new pricing policy by the government , local players might look for new ways to boost drug discovery, reducing time to market the products and squeezing costs along the whole value chain .

As a catalyst to Indian pharmaceutical industry, what in your opinion are the challenges in regulation that need to be addressed?

As the pharmaceutical innovation is at its peak, quality for the products has become a major concern.

The industry is facing stricter regulations on manufacturing and quality practices in the domestic as well as the international markets. Consumers are also becoming more aware about 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. Issues related to conducting ethical clinical trials and stringent GMP practices need to addressed.

How do you plan to leverage on GOI's Make in India initiative?

Healthcare has become one of the key priorities of the Indian Government and it is launching new policies and programmes to boost local access and affordability to quality healthcare. The policies will make India a growing market, a potential competitor or a partner in manufacturing and R&D, and a location for clinical trials.

The arrival of Goods and Services Tax (GST) may prove to be a strong incentive for greater streamlining, which could have potential positive impact to the final cost of medications in a price-sensitive market. However, India historically has a pharma supply chain with a number of stops between the initial production and final consumer. Logistics comprises 45-55 per cent of the costs in the Indian pharmaceutical supply chain from factory to shelf.

In order to meet the needs of its vast population, Government should provide drugs at the right price with improvements to local supply chains.

Your thoughts on budget 2017's impact on Pharma industry?

Budget was balanced from fiscal incentives perspective and a regulatory angle. The Budget has a good number of positive measures aimed at offering incentives to different stakeholders. The Government has shown its clear intention towards fast-tracking inflow of FDI, and the scrapping of FIPB is a notable step that would go a long way in supporting the objective of ease of doing business. Certainly it missed certain agendas such as there has been no announcement on incentives to research innovation and active pharmaceutical ingredients. Corporate Tax reduction and job creation proposal were also missing.

Kindly outline the future road map of your company.

Clearsynth intends to be the catalyst in accelerated discovery via synthesis of complex and difficult to make compounds. The Company is expanding its footprint in markets beyond North America & Europe. It is dedicatedly developing future molecules to meet the requirements of pharmaceutical industry. The company is also targeting new sectors such as enzymes, natural extracts, vitamins, hormones and petrochemicals. It aims to be the global leader in synthesis and supply of isotope labeled research chemicals.