1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

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

 
• By Bowman Cox

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
Start Free Trial

Already a subscriber?

More from Manufacturing

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By Vibha Sharma

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 Vibha Ravi

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

 
• By Derrick Gingery

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?

More from Compliance

Zimbabwe Tackles Medicines Falsification With New Requirements For Pharma

 
• By Neena Brizmohun

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.

Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

 
• By Neena Brizmohun

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.