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

Pharmacy Urges US FDA To Disallow Levels Of DMF Solvent It Found In Valsartan

 
• By Joanne S. Eglovitch

The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.  

Valsartan-english

Online pharmacy Valisure has raised concerns about what it believes are risky levels of another probable carcinogen in valsartan, filing a citizen petition with the US Food and Drug Administration on 13 June requesting that the agency significantly lower the permitted daily exposure (PDE) limit of the residual solvent, called N-Dimethylformamide (DMF).

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

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

More from Compliance

US Pharma Tariff Reprieve May Be Ending

 
• By Jessica Merrill

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
• By Andrew McConaghie

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
• By Eliza Slawther

While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.