Green Chemistry in Real World Practices - Pharmaceutical Industry Experience

1. Green Chemistry in Real World Practice Case Study from Pharmaceutical Industry Nitesh H. Mehta Founder Director Newreka Green Synth Technologies Pvt. Ltd. Mumbai, India [email_address]

3. This is the only World that exists. Real World ?? There is no other world. Then why specifically say “Real World” ?? Green Chemistry in Real World Practice

7. E - Factor for Manufacturing Sectors Source: R A Sheldon E - Factor = Total waste generated per kg of Product Sector E - Factor Product Tonnage Oil Refining ≤ 0.1 10 6 - 10 8 Bulk Chemicals 1 – 5 10 4 – 10 6 Fine Chemicals 5 – 50+ 10 2 – 10 4 Pharmaceuticals 25 – 100+ 10 - 10 3

9. When to implement “Green Chemistry”? Pre Clinical No. of molecules very high Phase I No. of molecules still high Volumes involved very low Phase II Limited No. of molecules Volumes increased Phase III No. of molecules further shortlisted Volumes further increased (kgs to ton) Commercial DMF Filed Volumes high (tens of tons) Phase II & Phase III : Right time to start exploring “Green Chemistry” based processes. Will ensure next generation drugs are manufactured through Green Processes.

11. Founders Team of Technocrats from IIT Bombay passionate about Nature Foundation Principles of Green Chemistry, Green Engineering & Enviropreneurship Knowledge Base & Over 40,000 experiments conducted by Experience a dedicated team of 50 Chemists & Chemical Engineers. Service Customized & Sustainable Solutions to reduce E-FACTOR * * E-FACTOR = kgs waste generated per kg product Newreka : Brief Introduction

13. Solvent & Water contribute more than 90% of the Reaction Mass Source Data: ACS GCI Pharmaceutical Roundtable benchmarking exercise 2007 Average composition of Effluents will be similar. Recycle of Water & Solvent can take care of 90% of problem. Average Composition of Reaction Mass

14. Industry Pharmaceutical Customer One of the fastest growing Pharma Company in India Product Anti – Retroviral (or Anti – Aids) Drug Application prevents transfer of virus from mother to child Our Context Enable our customer to supply drug to patients at affordable price so that our next generation is not contaminated with the virus Convert entire API/Drugs synthesis Green Case Study

15. CONVENTIONAL SYNTHETIC CHEMISTRY PROCESS E-Factor 32 38 28 4 Effluent 1920 TPA 2280 TPA 1680 TPA 240 TPA Total = 6120 TPA (for 60TPA plant) (20,000 kgs per day) GREEN CHEMISTRY SOLUTION BY NEWREKA E-Factor 6 6 1 4 Effluent 360 TPA 360 TPA 60 TPA 240 TPA Total = 1020 TPA Case Study: Reducing E-Factor & Improving Yield Stage III Chlorination Stage IV Reduction Stage V Stage II Nitration Stage I Diazo. & Hydrolysis Stage VI Stage II Nitration Stage III Chlorination Stage IV Reduction Stage I Diazo & Hydrolysis Stage VI Stage V

16. CONVENTIONAL SYNTHETIC CHEMISTRY PROCESS Th. Yield 1.01 1.41 1.12 0.826 = Overall Yield 1.317 Yield 0.80 0.53 1.05 0.73 = Actual Yield 0.325 (25% of Th.) GREEN CHEMISTRY BASED PROCESS Th. Yield 1.01 1.41 1.12 0.826 Yield 0.95 1.38 1.10 0.79 = Actual Yield 1.140 (86% of Th.) 250% Improvement in Yield Case Study: Improving Yield & Reducing E-Factor Stage III Chlorination Stage IV Reduction Stage V Stage II Nitration Stage I Diazo. & Hydrolysis Stage VI Stage II Nitration Stage III Chlorination Stage IV Reduction Stage I Diazo & Hydrolysis Stage VI Stage V

17. Case Study: Improving Yield & Reducing E-Factor

23. Our world needs Chemists & Chemical Engineers operating from larger context of : “ Making a Difference to the world through their work”. Opportunities for all of us

24. Thank You & Wish all of You a “ Greener Future” from Team Newreka