The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
Menon has over 41 years of diverse experience in some of the premier multinational and Indian companies in the chemical and power industry
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
India will become a digital health leader, as we have the world’s best technical manpower required and our data is the cheapest in the world, approaching 100 percent coverage
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