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Lupin Bioresearch Center (LBC), an integral unit of Medical Research of Lupin Limited, is continuously providing support to a variety of clinical development services. This includes the conduct of bioavailability and bioequivalence studies for the Generic and Branded products of Lupin and its subsidiary companies across the globe. In FY2018, LBC has made a rapid progress in new areas of pharmaceutical innovation for conduct of Nasogastric in-vitro studies and in-vitro and in-vivo PK studies on MDI and DPI Inhalation products. LBC is now venturing into expanding its outreach for in-vitro characterization of its ophthalmic product(s) for regulatory submissions.
In addition, LBC has always focused on compliance with regulatory requirements. In June 2017, LBC was successfully inspected by the US FDA without any 483 observations. A separate compliance and audit group (CAG) has been established in order to improve and sustain regulatory compliance for all clinical research studies. LBC, for the ﬁrst time, completed 2 in-vitro studies on inhalation products and submitted the same to the US FDA. As part of Lupin’s ANDA submissions program, LBC has completed 47 studies and cumulatively accounted for development of 235 regulatory- compliant analytical methods for this ﬁnancial year.