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 sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
The approval further adds to Biocon’s portfolio of complex drug products
This project is supported by the Irish Government through IDA Ireland
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Revolutionary technology will further boost OneSource’s scientific services offerings
Dr. Reddy's Laboratories has reported total income of Rs. 7,672.7 crores during the period ended June 30, 2024
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
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