US FDA completes inspection of Lupin's Mandideep location
Lupin has announced today the completion of United States Food and Drug Administration (US FDA) inspections carried out at its Mandideep location. Lupin's Mandideep location houses the company's cardiovascular "Pril" API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility. These inspections were carried out between November 26 and December 4,2018.
The inspection at Unit-2, the Cardiovascular "Pril" API facilities closed with 4 observations.
The inspection at Unit-I, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and 8 observations for the Cephalosporin Solid Oral Dosage Form facility.
The observations are largely procedural in nature with some gaps identified in the aseptic processing areas of the Cephalosporin API block and the company is confident of addressing them satisfactorily.
As a company, Lupin has committed to an enhanced Quality Management System and Compliance Sustainability Plan. The Lupin Mandideep site is already executing the plan, which also serves to address some of the concerns ra ised during this inspection.
There are no new DMF and ANDA applications pending for review or approval from Lupin's Mandideep facilities.
Shares of LUPIN LTD. was last trading in BSE at Rs.859.05 as compared to the previous close of Rs. 888.05. The total number of shares traded during the day was 175454 in over 3759 trades.
The stock hit an intraday high of Rs. 889.2 and intraday low of 849.6. The net turnover during the day was Rs. 151829402.