The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA
The facility is among 12 centres established worldwide, and the first in Asia
As a global mushroom biotechnology group, Mycelium Biotechnology is engaged in mushroom growing, global distribution and offering biotechnology and nutraceutical solutions through global partners
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products
Center of Excellence for Molecular Diagnostics and Proteomics will enable affordable diagnostics for infectious diseases in India
The plant is expected to start commercial operations from Q4FY24
The management believes that its strong product pipeline, diversified innovative product portfolio, continued expansion into new geographies and FGMP accreditations will help sustain the growth momentum in the coming few years
This facility will design & develop instruments, perform product reliability performance testing and verification
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