U.S. FDA Issues Import Ban On Apotex Drugs Made In India Plant

Another drug-production plant in India has been banned from imports to the U.S., this time that of Canada's Apotex, for all but one of the drugs it produces in Bangalore.

Another drug-production plant in India has been banned from imports to the U.S., this time that of Canada's Apotex, for all but one of the drugs it produces in Bangalore. The U.S. FDA issued the ban on the drugs, with the exception of its Riluzole (rilutek) for treating Lou Gehrig's disease, citing the plant's failure to meet good manufacturing practices. Apotex, which markets more than 300 generics, did not comment on the FDA action. The ban puts Apotex in the same league as Ranbaxy Laboratories and Wockhardt for drawing U.S. bans on their India plants. (Click here for more

)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from India

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By 

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

 

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.

Sun’s Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 

Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

More from Focus On Asia

Sun’s Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 

Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?

Activist Investor Vs. Japan Pharma: ASKA Plans Poison Pill As Dalton Pushes For MBO

 
• By 

While ASKA plans to dilute the holding of largest investor Dalton by issuing new shares, the US investment firm continues to push a management buyout option to the mid-sized Japanese pharma company.

China’s Mid-Cap Companies Thriving On Big Pharma Deals

 

Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.