US FDA Expectations For Removing Nitrosamines From All APIs, Drug Products

Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.  

chemistry
time to break up the nitrites and amines

The US Food and Drug Administration in 1 September guidance advises manufacturers to assess the nitrosamine impurity risks associated with all chemically synthesized active pharmaceutical ingredients and all approved or marketed drug products that contain those APIs or other sources of nitrosamines by 1 March 2021.

They should follow up with confirmatory testing and submission of any required changes in their drug applications, starting immediately for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Manufacturing

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By 

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By 

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

More from Compliance

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By 

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By 

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?