Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action

The scrip declined 2.49 percent to close at Rs 743.95 on the BSE. During the day, it dropped 5.43 percent to Rs 721.50

Press Trust of India May 27, 2019 16:54:26 IST
Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action
  • On the National Stock Exchange (NSE), shares fell 2.38 percent to close at Rs 745.10 apiece

  • In terms of traded volume, 2.56 lakh shares were traded on the BSE and over 32 lakh shares on the NSE during the day

  • The drug maker on Monday said the US health regulator made two observations after inspection of its Goa plant

New Delhi: Shares of Lupin fell 2.5 percent on Monday after the US health regulator made two observations following the inspection of its Goa plant and cautioned that the facility may be subject to regulatory action.

The scrip declined 2.49 percent to close at Rs 743.95 on the BSE. During the day, it dropped 5.43 percent to Rs 721.50.

On the National Stock Exchange (NSE), shares fell 2.38 percent to close at Rs 745.10 apiece.

In terms of traded volume, 2.56 lakh shares were traded on the BSE and over 32 lakh shares on the NSE during the day.

Lupin shares fall 25 after USFDA says Goa facility may be subject to regulatory action

Representational image. Reuters

The drug maker on Monday said the US health regulator made two observations after inspection of its Goa plant and cautioned that the facility may be subject to regulatory action and it may withhold approval of pending applications in which this facility is listed.

The company has received a communication from the US Food and Drug Administration (USFDA), classifying the inspection conducted at its Goa facility between January 28 and February 8, 2019, as Official Action Indicated (OAI). The inspection at the Goa facility had closed with two observations, Lupin said in a regulatory filing.

"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company added.

The Mumbai-based drug maker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility.

The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome, it added.

Updated Date:

Find latest and upcoming tech gadgets online on Tech2 Gadgets. Get technology news, gadgets reviews & ratings. Popular gadgets including laptop, tablet and mobile specifications, features, prices, comparison.

also read

Zydus Cadila gets USFDA nod to market blood pressure lowering drug in the US
Business

Zydus Cadila gets USFDA nod to market blood pressure lowering drug in the US

Drug firm Zydus Cadila on Tuesday said it has received final approval from the US health regulator to market Atenolol and Chlorthalidone tablets USP, used to treat high blood pressure, in the US

After Ranbaxy saga, USFDA gets cracking on drug facilities in India
Business

After Ranbaxy saga, USFDA gets cracking on drug facilities in India

The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India.<br /><br />

Dr Reddy's Lab recalls Famotidine tablets from US market as drug fails impurities specifications
Business

Dr Reddy's Lab recalls Famotidine tablets from US market as drug fails impurities specifications

As many as 5,69,376 bottles of Famotidine tablets, 10 mg belonging to multiple lots packaged in 30-count, are being recalled nationwide.