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
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
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
Within the API segment, ~20% of the revenues came from the domestic market and ~80% from the exports market
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
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