The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co
The proposed initiative is conceptualised with an objective to identify, support, and promote innovative research ideas in healthcare research
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
This FDC has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) in a sustained release (SR) formulation
None of the observations are related to data integrity and management believes that they are addressable
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