Vega Life Sciences Warning Letter Shows Difficulty Of Applying Drug GMPs To API Solvent Recyclers

Recycling offers economic and environmental benefits, but risks introducing potentially carcinogenic impurities. Company barred from US market.

Warning hazard sign and signage man falling
a point of no return • Source: Shutterstock

A recent US Food and Drug Administration warning letter provides more insight into how difficult it will be for active pharmaceutical ingredient manufacturers to retain the economic and environmental benefits of solvent recycling without risking the introduction of potentially carcinogenic impurities such as nitrosamines into drug products.

The warning letter the agency sent on 17 June to Vega Life Sciences Private Ltd., an API solvent recycler...

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 Compliance

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By 

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

More from Pink Sheet

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.