Drug Approval | June 16, 2023
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
The company will submit its comprehensive response on these observations to the US FDA
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
This fresh infusion of capital will enable ImmunoACT to fast track the additional supply of the lead candidate HCAR-19
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
Concept Medical’s manufacturing arm has reduced its carbon footprint via in-house efficiency improvement programmes & green infrastructure
The facility will have a capacity to manufacture upto 3 million tubes monthly
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