TCG Lifesciences, a part of the The Chatterjee Group (TCG) which controls Haldia Petrochemicals Limited in West Bengal, has received the US FDA approval for its chemical development and manufacturing facility in Hyderabad.
TCG Lifesciences, Clininvent Research, a 100 per cent subsidiary of The Chatterjee Group, has passed successfully the pre-approval inspection of the manufacturing plant, a company statement said on Tuesday, adding that the site was found to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP).
MD of TCG Lifesciences said "this marks another step for the TCG group for providing US customers with innovative high quality and small molecule cGMP drug development synthesis, services covering studies, clinical trials and commercial production.
"The key differentiators for TCG Life Sciences was its ability to handle very complex synthesis challenges and deliver high-end analytical and regulatory quality systems".
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