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
The RTP manufacturing facility will support the company's clinical studies and early commercial launch in North America and Europe
The facility will manufacture its Herceptin biosimilar, Tuznue
The awards will be conferred to the winners at the annual summit of OPPI, scheduled on March 23-24
The facility will supply clinical trial materials for the development of vaccines and biologics up to Phase II stage and is expected to be fully operational by early 2023.
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