United States Food and Drug Administration (USFDA) has completed inspections at Lupin’s 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-1, 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.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.