The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
Granules now have a total of 53 ANDA approvals from USFDA
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
The company will not receive any proceeds from the offer as all of it will go to the promoter selling shareholder.
The company has been issued ‘Form 483’ with two observations
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