Successful USFDA Analytical inspection – Lambda Canada Facility
We take immense pleasure in informing the successful closure of the USFDA inspection of our Toronto facilities (Lambda Canada) conducted between 08th May 2017 to 12th May 2017. There were no inspectional observations and no FDA 483s’ were issued for the ANDA submission studies inspected. Inspection was conducted as a part of routine Bioequivalent Clinical Bioresearch Monitoring (BIMO) inspection program of USFDA wherein analytical phases of multiple selected studies were reviewed by the inspector.
We have successfully completed a number of USFDA submission studies at all our global locations: Ahmedabad and Mumbai, India and Toronto, Canada (including First-To-File studies and Patient based Pharmacokinetic studies) over the last couple of years and undoubtedly, this is yet another feather in our cap as it reinforces our robust systems, processes and our overall commitment to Quality and International Regulatory Compliance in the Bioanalytical domain.
We seek this opportunity to thank you once again for your continued support and patronage of Lambda Therapeutic Research for your ANDA submissions.