Drug Approval | March 27, 2023
Briefs: Morepen Laboratories and Zydus Lifesciences
The company is addressing these observations
The company is addressing these observations
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
Zydus becomes the only Indian oncology player to venture into prognosis and diagnosis along with treatment planning
The company will address the observations within a stipulated timeline working with the regulators
MonoFerric, iron isomaltoside 1000 solution for injection/infusion, is a rapid, single dose IV iron developed to reduce the number of infusions
The company has reported total income of Rs. 4138.6 crores during the period ended June 30, 2022.
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The drug will be manufactured at the group’s topical facility at Ahmedabad
Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
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