The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
In fact, the overall CPHI Pharma Index – a collateralised metric of all major ranking categories – has risen by more than 8%, the largest year-on-year gain in the survey’s six year history
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
This will enable the company to consume 100% of the solar energy to be supplied by Ethan Energy India Private Limited from their 10 MW Solar Energy plant
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
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)
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
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