Drug Approval | March 22, 2023
Zydus granted Orphan Drug Designation by USFDA for ZYIL1
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions
Marksans' OTC Famotidine Tablets USP are acid reducers
The inspection concluded with no observations
Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Subscribe To Our Newsletter & Stay Updated
