Hyderabad: TCG Lifesciences, part of New York based The Chatterjee Group, promoted by Dr Purnendu Chatterjee, has today announced that it has received the USFDA approval for its chemical development and manufacturing facility in Hyderabad.
Supported by a strong talent pool of over 800 qualified scientists of TCG Lifesciences, Clininvent Research Pvt Ltd, the 100 per cent subsidiary of the company, has successfully passed a pre-approval inspection as a manufacturing plant, by the US Food and Drug Administration (USFDA). The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP).
The chemical development and manufacturing facility is located at Anantaram in Hyderabad and boasts of manufacturing advanced intermediates and Regulatory Starting Materials (RSMs) and custom manufacturing of New Chemical Entities (NCEs). The plant is equipped with multiple reactors totaling of a huge scale of production capacity.
Swapan Bhattacharya, Managing Director, TCG Lifesciences says, “This marks another important step for the TCG group in providing the US customers with innovative, high quality and integrated small molecule cGMP drug development synthesis services, covering IND enabling studies, clinical trials, and commercial production. At the same time, it marks our entry into the high growth generic APIs and intermediates domain for regulated markets. The key differentiators for TCGLS are our ability to handle very complex synthesis challenges, deliver comprehensive CMC packages and implement high end analytical and regulatory quality systems.”
“The pre-approval inspection was triggered by a DMF filing by one of our clients and subsequent ANDA filing” mentioned Subho Roy, Vice President, TCG Lifesciences....