USFDA makes 22 observations post inspection of Lupin's Mandideep facilities

NEW DELHI: Drug major Lupin Wednesday said the US health regulator has made a total of 22 observations after inspection of its facilities located at Mandideep in Madhya Pradesh.

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," Lupin said in regulatory filing.

Lupin said 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 raised during this inspection,” the company added.

There are no new drug master file and Abbreviated New Drug Application (ANDA) pending for review or approval from Lupin's Mandideep facilities.

Shares of Lupin were trading 2.34 per cent lower at Rs 867.25 apiece on BSE.