FDA bans imports from Canadian drugmaker Apotex's India plant

MUMBAI Thu Apr 3, 2014 12:47pm IST

Related Topics

Stocks

   

MUMBAI (Reuters) - The U.S. Food and Drug Administration banned imports from Canadian drugmaker Apotex Inc's manufacturing plant in India for not complying with quality standards, the latest in a series of sanctions against medicines produced in India.

Drugs made at the plant, based in Bangalore, will be detained without physical examination because the factory did not meet the FDA's good manufacturing practices, the agency said on its website on Wednesday.

The ban excludes Riluzole, a drug used to treat amyotrophic lateral sclerosis, commonly called Lou Gehrig's disease. (r.reuters.com/pug23v)

The ban on Apotex's factory comes after manufacturing plants of top Indian drugmakers like Ranbaxy Laboratories Ltd (RANB.NS), Wockhardt Ltd (WCKH.NS) and Sun Pharmaceutical Industries Ltd (SUN.NS) were barred from exporting to the United States due to quality concerns.

The FDA has stepped up scrutiny of medicines made in India, which supplies about 40 percent of generic and over-the-counter drugs to the United States.

FDA Commissioner Margaret Hamburg in February said the agency was not unduly targeting drug companies in India, but "undertaking our required regulatory activities" needed to protect public health in the United States.

Apotex currently makes about 260 generic drugs, or copies of name-brand pharmaceutical products, that are sold in Canada and exported to more than 115 countries. The company's sales exceed C$1 billion a year, according to its website.

Ontario-based Apotex was not available to comment outside of regular business hours and calls to its Bangalore research facility went unanswered.

(Reporting by Zeba Siddiqui; Editing by Matt Driskill)

FILED UNDER:

Fast-tracking Projects

REUTERS SHOWCASE

Oil Prices

Oil Prices

Oil resumes slide after brief rebound on short-covering.  Full Article 

Space Programme

Space Programme

ISRO tests its heaviest space launch vehicle, eyes global market   Full Article 

Coal India Strike

Coal India Strike

Coal India workers threaten five-day strike, stokes output worries  Full Article 

Gold Discount

Gold Discount

Dealers offer gold discount for first time in five months  Full Article 

Lakhvi Granted Bail

Lakhvi Granted Bail

Pakistan court bails man accused of masterminding Mumbai attack  Full Article 

GST Bill

GST Bill

Cabinet clears bill for nationwide goods and services tax.  Full Article 

Aviation Sector

Aviation Sector

Breakingviews: SpiceJet rescue is no fix for India aviation woes.  Full Article 

Global Economy

Global Economy

Fed confident on U.S. growth, opens door wider to rate hike.  Full Article 

Reuters Poll

Reuters Poll

BSE Sensex to hit 32,980 by December 2015  Full Article 

Reuters India Mobile

Reuters India Mobile

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