Lupin resolves USFDA's concerns on Mandideep unit

Lupin resolves USFDA's concerns on Mandideep unit



The company had received a warning letter from the USFDA for its Mandideep site in May 2009, after which it made significant enhancements and took appropriate corrective actions, Lupin said in a statement. The facility was re-inspected in November 2009 and found to be compliant with the US drug regulator's guidelines.

"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," Lupin Group President and Executive Director Nilesh Gupta said.

According to industry expert, Lupin would now be able to seek FDA's approval for its durg applications from this unit. The company said, the regulator had also inspected the company's Aurangabad-based liquid (drugs in liquid form) manufacturing site and Indore-based oral solids and oral contraceptive manufacturing site.

"These recent successful inspections bring the company a step closer to launching liquids and Oral Contraceptives," Lupin said. Earlier, the UK MHRA and the Australian TGA had also conducted a joint inspection of the Mandideep unit and found it acceptable, it added.

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