The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
The new production line is equipped with the latest advanced manufacturing system to produce quality products of Alkaloids & APIs used in a wide range of pharmaceutical applications
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
The company will reduce wastage substantially, increase productivity, enhance environmental consciousness, save energy, optimally use natural resources, and expand its market penetration
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
Acquisition expands Merck’s growing hematology portfolio
The newly built complex of RRIUM, which will be under CCRUM, the apex government organization for research in Unani Medicine
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