Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
The company will submit its comprehensive response on these observations to the US FDA
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
The new recycling facility, Recover Louth, is the second addition to Coveris’ closed loop recycling business segment
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.
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