RODRIGO O. M. A. DE SOUZA
Biocatalysis and Organic Synthesis Group, Chemistry Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil

Abstract

Brazil produces only 5% of the active pharmaceutical ingredients needed to the manufacture of medicines. Recent changes on regulations and the COVID-19 pandemic could open the Brazilian market to a new window of opportunity where continuous manufacturing can play an important role to secure pharmaceutical supply chain.

The COVID-19 pandemic has profoundly exposed how much Brazil is dependent on imports of active pharmaceutical ingredients - APIs - and on intermediaries to manufacture its medicines. Internalizing and mastering the production of APIs is not simple and involves understanding risks and challenges that lie ahead. Nowadays, Brazil produces only 5% of the API´s needed to the manufacture of medicines, and according to ABIQUIFI (Brazilian Association for Fine Chemical Industry), would need to invest US$ 1 billion dollars in development and infrastructure to increase national production to 20% within five to ten years. Imports are predominantly from Asia (70%) but Europe (Germany, Switzerland and Italy, in general) and North America (USA) plays an important role on the Brazilian market.

This scenario is very similar to what we have seen on the history of the pharmaceutical industry in Brazil in the earlies 30-40´s. In the post-war period (after 50´s), the process of internationalization of the Brazilian pharmaceutical industry begins to consolidate, contributing to stablish around 600 companies in Brazil during the 60´s. Besides the huge advances made during t ...