Drug Approval | September 30, 2022
USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility
The company will address the observations within a stipulated timeline working with the regulators
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
Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder
Zydus unveils its ‘innovation and care’ centric corporate brand identity
The first Phase III and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine
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