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

  • Most Popular
  • Most Shared

Economy

REUTERS SHOWCASE

RBI Annual Report

RBI Annual Report

RBI reiterates commitment to bring down inflation .  Full Article 

Economic Pulse

Economic Pulse

Economy to grow 5.8 pct in 2014/15, says Mayaram.  Full Article 

Monsoon Update

Monsoon Update

Monsoon to display lull as floods ease.  Full Article 

Regulatory Troubles

Regulatory Troubles

U.S. regulator alleges Dr Reddy's breached packaging rules  Full Article 

Defence Sector

Defence Sector

Indian firms tool up for defence orders on Modi's 'buy India' pledge  Full Article 

Factory Activity

Factory Activity

Economy fears deepen as August HSBC flash PMI at three-month low  Full Article 

Fed Minutes

Fed Minutes

Fed notes labor market progress, but not convinced yet - minutes  Full Article 

Reuters India Mobile

Reuters India Mobile

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