FDA Cites 22 Observations at Lupin’s India Mfg SiteBy
Lupin, a Mumbai, India-headquartered pharmaceutical company, has received 22 observations from the US Food and Drug Administration (FDA) across its three facilities in Mandideep, India, which Lupin says are “largely procedural in nature.” Lupin’s Mandideep site houses the company’s cardiovascular active pharmaceutical ingredient (API) facilities, cephalosporin API facilities, and its cephalosporin solid oral dosage form facility.
The FDA completed inspections carried out at the Mandideep site between November 26 and December 4, 2018. The inspection at Unit-2, the cardiovascular “pril” API facilities, closed with four observations. The inspection at Unit-1, the cephalosporin facilities, closed with 10 observations for the cephalosporin API facilities and eight 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 said in a December 5, 2018 company statement on the Bombay Stock Exchange. “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 raised during this inspection.”
The company said there are no new drug master files and abbreviated new drug applications pending for review or approval from Lupin’s Mandideep facilities.