USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The common stock of Concert will no longer be listed for trading on the Nasdaq Global Market
Agasta Software is engaged in research, development and commercialization of medical devices
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
India formulation sales at Rs. 3,391.9 crore, up 7.1% over Q3 last year
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
The Halol facility was placed under Import Alert by USFDA.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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