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.
It includes both public and private health facilities including hospitals, clinics, diagnostic laboratories, and imaging centers
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
Company provides anticipated impact to second quarter 2022 financial results due to recently completed business development transactions
CEPI will provide seed funding of up to US$2.5 million to Codiak BioSciences.
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