Drug Approval | July 08, 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
These medicines have low risk of hypoglycemia, provide beta cell protection, offer cardio-renal benefits and are safe for patients with kidney or liver conditions and senior citizens
Site Enhances New Modality CRDMO Platform Capacity for Customers
The new facility will be delivered through an investment of approximately CHF 500 million and is expected to be completed in 2026
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The JV is funded by Boehringer Ingelheim as lead investor with 30 million EUR and by Evotec and bioMérieux with 5 million EUR each.
The AICVD tool can predict the risk of cardiovascular disease.
The vaccine is under FDA review
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
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