Biotech | May 29, 2022
Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)
It is a new class of drug that treats uncontrolled LDLCholesterol, despite the use of a maximum tolerated dose of statins
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
The drug is indicated for use in combination with other drugs
It is only the second generic application approved by the USFDA
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
OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)
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