Drug Approval | October 18, 2023
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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