The award is for development of Nafithromycin, which is the first ever multi-drug resistant pathogen active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia
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 aims to benefit approximately 4.5 crore families with six crore senior citizens with Rs. 5 lakh free health insurance cover on a family basis
The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9
Wanbury receives CEP approval from EDQM for launch of Dextromethorphan API
The recent inspection covered both cGMP and PAI processes
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
TTP Group is a leading engineering firm specializing in biotech and pharmaceutical industry
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
Subscribe To Our Newsletter & Stay Updated
