This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
Company is investing more than €100 million in the expansion of the Halle site
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA in the United States
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world
First and only PARP inhibitor to improve invasive disease-free survival in patients
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