Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
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Joint Drugs Controller (India) Dr PBN Prasad shared his views about working during harsh COVID-19 pandemic days
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
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
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
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)
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