Shares of Lupin fell nearly 4% in intraday trade on Friday after the U.S. Food and Drugs Administration (FDA) issued observations for the pharmaceutical company’s Pithampur unit. Headquartered in Mumbai, the company in an exchange filing said that the U.S. drug regulator has issued Form 483 with ten observations for its Pithampur unit. The inspection at Lupin’s Pithampur unit-2 manufacturing facility was carried out between March 21 and March 29, 2023.
“We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance across all our facilities,” Lupin said in a BSE filing on March 30.
The U.S. FDA issues a Form 483 when the FDA field investigator finds deficiencies in quality system of a facility or conditions that violate the food, drug, or cosmetic act.
Few months back, the U.S. FDA issued a Form 483 with eight observations for its Mandideep-based manufacturing facility. The regulator inspected the drug maker's Mandideep Unit-1 facility from November 14 to November 23, 2022.
Reacting to the news, Lupin shares declined 3.7% to hit an intraday low of ₹628.10 after opening lower at ₹641.10 against the previous closing price of ₹652.45 on the BSE. There was surge in volume trade as 0.8 lakh shares changed hands over the counter compared with the two-week average volume of 0.31 lakh stocks.
At 1:20 PM, Lupin share price was quoting at ₹647.05, down 0.8%, while the market capitalisation stood at ₹29,440 crore. At the current price, the pharma heavyweight was up 11% against its 52-week low of ₹583.05 touched on May 25, 2022. The stock hit a 52-week high of ₹798.90 on April 5, 2022.
Lupin shares recovered from day’s low after the company informed the exchanges that it has received the U.S. FDA approval for Tenofovir Alafenamide Tablets, used for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. This product will be manufactured at Lupin’s Nagpur facility in India.
“The company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tenofovir Alafenamide Tablets, 25 mg, a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc,” Lupin said in a release today.
Tenofovir Alafenamide Tablets, 25 mg, (RLD Vemlidy) had estimated annual sales of $531 million in the U.S., as per IQVIA MAT December, 2022.
Earlier this week, the company received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Ingrezza Capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc. Valbenazine is a medication that treats involuntary movements caused by tardive dyskinesia.
Besides, it also received tentative approval from the U.S. FDA for Obeticholic Acid Tablets for treatment of a certain liver disease. The regulator has given a nod for its Abbreviated New Drug Application (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg, to market a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.