1. Generics Bulletin
  2. >>Business
  3. >>Manufacturing

US FDA Scrutinizes Process Risks After Nitrosamines Found In ARBs

 
• By Bowman Cox

There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.

FDABldg1ExteriorWithCircle_1200x675
agency grows more cautious about impurities

The US Food and Drug Administration is paying more attention to process-related impurities now that process-related potential carcinogens have been found in certain blood pressure and heart failure medications, says Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

Even as the agency clamps down on the impurities, called nitrosamines, Woodcock emphasized in a 28 August statement that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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
Start Free Trial

Already a subscriber?

More from Manufacturing

More from Business

Bio-Thera And SteinCares Add Mega-Blockbuster Dupilumab To Latin America Alliance

 
• By Dean Rudge

Bio-Thera Solutions is back with its third agreement with Costa Rica-based SteinCares for the supply of a biosimilar in Latin America – this time for the Chinese firm’s proposed rival to Sanofi and Regeneron’s Dupixent (dupilumab)

Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

 
• By Dean Rudge

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

EMA Greenlights Give Eylea And Stelara Biosimilars Momentum Across Europe

 
• By Dean Rudge

The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.