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 current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore
The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come
Advent will also be making an open offer to acquire additional 26% of the outstanding equity shares of the company from the public shareholders.
China is now focusing on establishing volume and enhancing capabilities for innovative high value drug production
This partnership stemmed from a successful customer-supplier relationship spanning several years.
Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
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