Drugmaker Lupin’s Pithampur facility in Madhya Pradesh has received six regulatory observations from the United States Food and Drug Administration, the company said.
The company’s track record has been largely free of major incidents over the last five years, after its Mandideep site received a warning letter in May 2009.
“Two Lupin facilities, the Lupin Bioresearch Pune and its facility at Pithampur, near Indore, were audited by the US FDA in November 2014 and January 2015, respectively,” the company said. And while the Pune facility received no observations, the Indore facility received six 483 observations, the company said.
However, the company has since received one abbreviated new drug approval and two site-transfer approvals in the US, it added. This means the company has since received an approval to sell one more product in the US, besides clearance to move two more products to be made at the Pithampur facility, a source familiar with the development explained.
The regulatory observation that Lupin had received is a preliminary one made by the US regulator on a 483 form and companies are given time to sort out the concerns that have been raised. The company is off the hook if the regulator is satisfied with the measures taken by the company. Otherwise, depending on the nature of the transgression, the regulatory action could escalate into a warning letter and/ or an import ban on the product.
In fact, Lupin had received a USFDA warning on its Mandideep site in May 2009. But corrective measures were launched, and in seven months, the company sorted out its issues and received a clean chit from the regulator, the company management had then said.
The development comes even as other India-based drugmakers including Ranbaxy and Wockhardt face stringent USFDA action and bans on importing products from some of its facilities into the US. Other domestic drug companies including Sun Pharma and Ipca are also dealing with the USFDA action.
On Monday, Lupin shares fell 2.5 per cent on the development, to ₹1,648 on the BSE.