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.
Milan is also an important hub for the distribution of pharmaceuticals to the rest of Europe
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The interaction with key Government Officials and industry leaders led to a joint exploration of possible collaboration and investments in the Healthcare ecosystem between the two countries
Fully equipped labs with 75-member team set-up and made operational in <100 days
The facility is over 79,000 square feet and is equipped with packaging lines
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