FDA Clears Lupin’s Mandideep Site

The company said that in the ensuing seven months, it made enhancements and took appropriate corrective actions. The facility was reinspected in November 2009 and was found to satisfactorily address all concers related to the warning letter, and the compliance status was found to be acceptable.

In the last quarter, the FDA inspected two new Indian sites of the company at Aurangabad (liquids) and Indore (oral solids and oral contraceptives). Aurangabad was found acceptable with no 483’s and Indore was found acceptable with 483 observation, which was satisfactorily addressed before the close of the inspection. These recent sucessful inspections bring the company a step closer to launching liquids and oral contraceptives.

Earlier, the MHRA and TGA had also conducted a joint inspection of the Mandideep facility and had found it acceptable.

Nilesh Gupta, group president and executive director of Lupin, said: “We are very pleased that we have been able to satisfactorily adderss the US FDA’s concers and clear the status of Mandideep. We are very proud that our people have been able to make this happen. This achivement is even more commendable in current heightened regulatory environment and is strong testimony of how we are moving up the regulatory curve. With the recent inspections and satisfactory resolution of all pending concerns at Mandideep, all our facilities have now been inspected in the past year and have been found to be in good shape.”