Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per…
Tag: U.S. FDA
Zydus’ manufacturing plant gets 5 U.S. FDA observations
The U.S. Food and Drug Administration (U.S. FDA) has issued five observations, post inspection, to the manufacturing plant of Zydus in Moraiya, Ahmedabad. The inspection was conducted from October 5-13…
Dr. Reddy’s facility in Andhra Pradesh gets 2 U.S. FDA observations
A view of Dr. Reddy’s Lab facility near Hyderabad | Photo Credit: The Hindu The U.S. Food and Drug Administration (U.S. FDA) has issued two observations to a manufacturing facility…
Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.
Granules India seeks first mover advantage | Photo Credit: The Hindu Generic drugmaker Granules India has filed a Paragraph IV certification with the U.S. Food and Drug Administration (U.S. FDA)…