News | December 14, 2021
Lupin’s Goa plant receives EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated
FDA changes inspection classification of the facility to Voluntary Action Indicated
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
The product will be commercialized from Unichem's Ghaziabad plant
Collectively, these 10 laboratories are capable of processing about 10,000 samples in a day and deliver results within the given turnaround time
It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal
The company has has 10 existing labs in India
The campaign aims to increase awareness about Tuberculosis as a curable disease and promote early diagnosis.
In his new role as Managing Director India and Global Head, Partnerships and Innovative Finance, Singh will oversee the financial, human, and operational functions of the India office
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
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