Indian drugmakers bag 42 %of total market authorisations of USFDA last year

India now has the highest number of market authorisations granted by the US Food and Drug Authority (USFDA) so far along with a steady increase in the registration of manufacturing sites registered with the US regulator. Market authorisations are approvals given to Abbreviated New Drug Applications (ANDAs) that allow companies to launch a product in the US market. As per the latest industry data of the USFDA, market authorisations granted to Indian formulations companies with USFDA approvals stood at 6,316, which is highest in comparison to any other country as of April 2023. This includes authorisations granted to India subsidiaries situated overseas. There were 107 market authorisations granted by the US agency for First Time Generics out of which Indian origin companies bagged 41 which shows the `primacy’ of the Indian drug industry, according to R Uday Bhaskar, Director-General. Pharmaceutical Export Promotion Council (Pharmexcil).