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

Shares Hit Record

Sensex, Nifty rise to second consecutive record high

Sensex surges 500 points on BOJ easing, L&T gains

The BSE Sensex and Nifty surged to record highs for a second consecutive session on Friday after Bank of Japan's surprise expansion of its massive stimulus programme raised hopes for additional foreign inflows, boosting blue-chips such as Larsen & Toubro.  Full Article 

REUTERS SHOWCASE

Wilful Negligence?

Wilful Negligence?

SEBI piles pressure on Sahara to sell overseas hotels  Full Article 

Indian Economy

Indian Economy

India's fiscal deficit in H1 almost 83 pct of full-year target.  Full Article 

M&M Earnings

M&M Earnings

M&M Q2 net profit down 4 percent, hit by poor monsoon.  Full Article 

Ban on E-Cigs?

Ban on E-Cigs?

Govt considers ban on e-cigarettes, sale of single smokes.  Full Article 

Commodities

Commodities

Silver futures in India hit four-year low on global cues.  Full Article 

BOJ Policy

BOJ Policy

BOJ shocks markets with surprise easing as inflation slows.  Full Article 

Shadow Banking

Shadow Banking

China's shadow banking sector growing rapidly, third largest in world - FSB.  Full Article 

Reuters India Mobile

Reuters India Mobile

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