Lupin falls over 2% afer USFDA issues six observations for Madhya Pradesh unit

The Lupin stock fell in early trade today after the Mumbai-based drug firm said the US health regulator has issued six observations after the inspection of a unit of its Pithampur facility in Madhya Pradesh. The large cap stock fell 2.09% to 845 level in trade today compared to the previous close of 863 level on the BSE.

The stock has lost 9.01% during the last one year.

However, the stock managed to recover losses in afternoon trade and was trading 0.30% higher at 865.60 on the BSE.

The stock was trading above its 50 day and 200 day moving average of 844.35 and 863.89,  respectively.

9 of 37 brokerages rate the stock "buy" or 'outperform', nine "hold", 14 "underperform" and five "sell", according to analysts' recommendations tracked by Reuters.

The inspection of Pithampur Unit -2 was carried out by the United States Food and Drug Administration (USFDA) between January 14 and January 25, 2019, Lupin said.

"The inspection at Pithampur Unit-2 (Indore) closed with 6 observations," it added.

The company, however, did not provide any details about the nature of the observations.

The company is confident of addressing the observations satisfactorily, Lupin said.

The US health regulator issued observations by means of a FDA Form 483 notifying the company's management of objectionable conditions at the facility inspected.

Lupin last week said it has received approval from the US health regulator to market Levothyroxine Sodium tablets used for treatment of hypothyroidism.

The company has received an approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 25 microgram (mcg), 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, Lupin said.

The product is a generic version of AbbVie Inc's Synthroid tablets in the same strengths, it added.

In mid-January, Lupin voluntarily recalled 55,000 vials and 1,60,241 boxes of anti-bacterial drug Ceftriaxone for injection in various strengths from the US market. The company recalled specific lots of drugs due to the presence of particulate matter.

Lupin also recalled 2,87,784 bottles of Cefdinir for Oral Suspension, used to treat bacterial infections, for CGMP (Current Good Manufacturing Practice) deviations from the US market.

Meanwhile, the Sensex was trading 289 points lower at 35,735 and the Nifty was down 0.99% to 10, 674 in afternoon trade.

Edited by Aseem Thapliyal