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
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
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 US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Dr. Mandaviya urged the stakeholders to capitalize on the current opportunities
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
The facility will have a capacity to manufacture upto 3 million tubes monthly
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
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