NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
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 is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
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
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
The expansion makes Exothera one of the largest viral vector facilities in Europe
Data published in the prestigious journal ACS Central Science of the American Chemical Society
Subscribe To Our Newsletter & Stay Updated