Jubilant Life plunges 10 percent after FDA warning for U.S. plant

MUMBAI Thu Dec 5, 2013 4:32pm IST

Pharmaceutical tablets and capsules in foil strips are arranged on a table in this picture illustration taken in Ljubljana September 18, 2013. Picture taken September 18. REUTERS/Srdjan Zivulovic/Files

Pharmaceutical tablets and capsules in foil strips are arranged on a table in this picture illustration taken in Ljubljana September 18, 2013. Picture taken September 18.

Credit: Reuters/Srdjan Zivulovic/Files

Related Topics

Stocks

   

MUMBAI (Reuters) - Drugmaker Jubilant Life Sciences Ltd(JULS.NS) said on Thursday it had received a warning from the U.S. Food and Drug Administration over manufacturing practices at one of its U.S. facilities, sending its shares the limit-down 10 percent.

The FDA said it could withhold approval of new products from Jubilant HollisterStier LLC, a facility located at Spokane, Washington, until the company takes action to comply with the regulator's good manufacturing practices, Jubliant Life Sciences said.

Jubilant HollisterStier will respond to the warning on or before December 12 and will take corrective actions to ensure compliance with the FDA, it added.

The facility accounted for 7 percent of Jubilant Life Science's consolidated sales in the six months ended September.

Shares of Jubilant Life Sciences plunged 10 percent after the announcement, their steepest one-day fall in nearly six months, while the BSE Sensex closed 1.2 percent higher.

"We expect that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL (warning letter) will affect new approvals only," the company said in a statement.

Indian medicine makers, which produce nearly 40 percent of generic and over-the-counter drugs for the United States, have recently been battered by a rash of regulatory actions including a record fine for Ranbaxy Laboratories Ltd (RANB.NS) and what amounts to a ban by the FDA on a second plant for Wockhardt Ltd (WCKH.NS).

Jubilant Life Sciences, which makes generics and provides contract manufacturing services, has 10 facilities in India, the United States and Canada.

(Reporting by Sumeet Chatterjee in Mumbai; and Abhishek Vishnoi in Bangalore; Editing by Miral Fahmy)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared
People walk in the Wipro campus in Bangalore June 23, 2009. REUTERS/Punit Paranjpe/Files

Wipro Q4 net profit beats estimates, rises 29 percent

Wipro posted a 29 percent rise in its fourth-quarter net profit, beating expectations, helped by increased IT spending by its customers. For the quarter ended March 31, the company said it earned 22.27 billion rupees compared with 17.29 billion rupees a year earlier.  Full Article | Full Coverage 

REUTERS SHOWCASE

Literary Giant Dies

Literary Giant Dies

Nobel winner Garcia Marquez, master of magical realism, dies at 87.  Read 

Election 2014

Election 2014

India holds biggest day of voting with BJP gaining strength  Full Article | Full Coverage 

Insider Trading

Insider Trading

Ex-Goldman director Gupta starts prison term on June 17.  Full Article 

Market Eye

Market Eye

Sensex jumps 351 points, snaps 3-day losing streak  Full Article 

Expansion Plans

Expansion Plans

Reliance Industries, HPCL Mittal plan refinery expansions.  Full Article 

S&P on India

S&P on India

S&P: India's ratings to depend on next govt econ, fiscal policies.  Full Article 

Ambitious Aim

Ambitious Aim

In green car race, Toyota adds muscle with fuel-cell launch.  Full Article 

Deal Talk

Deal Talk

Piramal to buy 20 percent stake in Shriram Capital for $334 million.  Full Article 

Bond Market

Bond Market

A star abroad, RBI boss riles bond traders at home  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.  Full Coverage