NEW DELHI: Indian companies are expected to secure a 48-50 percent share of approvals for new drugs from the US Food and Drug Administration (USFDA) in the 2023 calendar year, similar to the previous year, noted analysts.
According to an analysis by Ashika Research, approximately 762-782 abbreviated new drug approvals (ANDAs) are anticipated globally from the USFDA.
“If we estimate that Indian companies hold a 48 percent share, the number of ANDA approvals for Indian companies is projected to be 365-375 in 2023, slightly more than last year’s figure of around 355.
“To comply with USFDA requirements, companies have focused on strengthening their processes with the assistance of global regulatory consultants, improved training, and automation in recent years” Ashika Research said.
“Additionally, there has been an increased overall focus on diversification, including facilities across geographies and third-party insurances,” Ashika Research further added.
