KVK Research Pleads Guilty To Adulterated Drug Distribution

The Generics Manufacturer Will Pay A Total Of $3.5m, Including Civil Liability Resolution

KVK Research and KVK Tech failed to notify the US FDA about the use of a foreign API manufacturing facility and submitted alleged false claims to governmental health programs.

Gavel and pills on a blue background.
• Source: Shutterstock

Pennsylvania-based KVK Research has pleaded guilty after it and its corporate affiliate KVK Tech were charged with two misdemeanor counts of distributing adulterated drugs into interstate commerce in violation of the US Federal Food, Drug and Cosmetic Act.

As part of a plea agreement, KVK Research agreed to pay a $1

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

More from Generics

More from Products

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By 

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Tetris Deal Falls Into Place For UK’s Aspire

 
• By 

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.