Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
The company is also looking at an inorganic opportunity over the next two years to have a commercially ready footprint in the US
The pooled prevalence of GERD in the Indian population is 15.6 %
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
ANVISA issues CGMP to Concord Biotech’s Unit I
This is the first and only oral once-a-day therapy for testosterone suppression in patients with advanced prostate cancer in India
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
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