Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate ...
Zydus Lifesciences receives USFDA approval to manufacture Enzalutamide tablets, a generic prostate cancer treatment drug, for ...
AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has ...
Hyderabad: Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration ...
Zydus Lifesciences received an Establishment Inspection Report (EIR) from the USFDA for its Ahmedabad facility. Shares rose ...
The drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district ...
Last week, brokerage firm UBS Securities also initiated a 'sell' call on Aurobindo Pharma, assigning it a price target of Rs ...
The inspection, which took place between September 23 and September 27, 2024, concluded with 4 observations from the ...
Biocon shares fell 2% to Rs 361.5 after the USFDA issued four observations following an inspection of its Bengaluru API facility. The company will address these within the stipulated time and does not ...
The inspection closed with 10 observations. The observations are of procedural in nature and will be responded to within the stipulated time.
Aurobindo Pharma receives USFDA approval for Cephalexin tablets, expected to launch in Q3FY25 with CGT designation.
The US Food and Drug Administration (USFDA) conducted a surveillance inspection of the API facility (Site 2), located at ...