Our Strategy and Approach

API Manufacturing Issues

Supply Chain Vulnerability

The COVID-19 pandemic has dramatically highlighted the extreme vulnerability in drug supply chains in both India and China. Continuous supply of drugs in healthcare delivery is necessary to ensure delivery of affordable healthcare and provide drug security.

Release and publication by the Government of India of a list of 53 APIs for which the country is heavily dependent on imports. The USA administration has released a list of 16 drugs that are in extremely short supply.

Safety

Some processes can result in carcinogenic impurities  e.g., N-Nitroso Dimethyl Amine.

Technology—Innovation Gap

Outdated processes still used to manufacture generic drugs e.g., Resolution of racemates.

Production processes are inefficient, and fraught with regulatory deficiencies.

Generic pharmas are not sufficiently focused on innovation to create improved syntheses and utilize modern technologies in manufacturing.

Strategy and Approach

Value Creation through Innovative Route Selection & Manufacturing Process Optimization

  • Incorporate advanced technologies into design of new routes and processes
  • Generate integrated technology package by initial scale up to 1-10 Kg
  • Strategic partnering for quality manufacturing

  • Implement changes to DMFs;  reduce costs, provide favorable EHS, develop sustainable “Green Chemistry”; FDA has promised favorable consideration for new DMFs with new technologies

Innovative process chemistry with new inventive and sustainable routes by modern technology will create a new era of quality manufacturing

  • Ensure uninterrupted supply of high-quality advanced intermediates that can be elaborated into bulk drugs
  • Develop new routes up to N-2 intermediate (>90% process innovation up to N-2); then partner our technology with a manufacturer for eventual cGMP scaleup
  • Develop new routes up to N-2 intermediate (>90% process innovation up to N-2); then partner our technology with a manufacturer for eventual cGMP scaleup
  • Our programs tackle APIs prioritized by market value, cost to manufacture and our ability to bring innovation to the synthesis;