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Regular-article-logo Tuesday, 29 April 2025

Lupin first to settle tiff with US drug cop

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OUR SPECIAL CORRESPONDENT Published 21.01.10, 12:00 AM

Mumbai, Jan. 20: Lupin has become the first Indian pharmaceutical firm to sort out its problems with the US Food & Drug Administration regarding deficiencies in processing and documentation standards at its Mandideep unit.

Seven months ago, the US drug regulator had issued a warning letter to the Rs 3,824-crore pharmaceutical company after investigation revealed shortcomings at Lupin’s plant.

Analysts said it was good news for Lupin and other drug makers such as Ranbaxy Laboratories and Sun Pharmaceutical Industries, who had been in a similar predicament. “The business will open up for Lupin and it can go faster into the market,” an analyst said.

The US regulator has turned stringent on issues such as quality, processing and documentation standards followed by pharmaceutical companies over the past couple of years.

Last year, US marshals, at the behest of the FDA, had seized drugs manufactured by Caraco Pharmaceutical’s Michigan facilities. Caraco is the US subsidiary of Sun Pharma.

In September 2008, the US FDA had banned Ranbaxy from selling about 30 drugs after it detected manufacturing defects at its Paonta Sahib and Dewas facilities.

Both companies have been working with the regulator to take corrective steps. Recently, the FDA had re-inspected one of the facilities of Ranbaxy.

Lupin today said it had received official communication from the FDA on the satisfactory resolution of the warning letter issued by it.

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