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
The company will engage with the agency to resolve the import alert at the earliest.
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
There is a great opportunity for utilizing traditional medical practices like Ayurveda in Value Based Healthcare
The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
The company has been issued ‘Form 483’ with two observations
Subscribe To Our Newsletter & Stay Updated
