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The Lupin Bioresearch Centre (LBC) located in Pune, India has continuously maintained its stellar performance on the regulatory compliance front with successful UK MHRA, US FDA, DCGI and NABL inspections in FY 2017 for conducting bioequivalence studies for Lupin’s generic products and branded formulations. LBC has also managed Lupin’s outsourced bioequivalence studies including project management.
LBC has both clinical and bioanalytical capabilities - 2 in-house clinics and bioanalytical labs equipped with 14 high-end LC-MS/MS systems, 2 Ion Chromatography (IC) systems, 1 MSD / ELISA systems for PK/PD and Immunogenicity studies of Biosimilar products. LBC supports global clinical projects for Lupin’s R&D verticals in India, Japan and US. In FY 2017, LBC established the in-vitro BE laboratory to conduct regulatory studies for Lupin’s respiratory product development program and also established efficient Biometrics department for its ANDA program. LBC completed 42 full studies during FY 2017 at its site, taking the cumulative tally to 267 studies and established about 200 validated analytical methods till date.